Trial Outcomes & Findings for FPT155 in Patients With Advanced Solid Tumors (NCT NCT04074759)
NCT ID: NCT04074759
Last Updated: 2025-01-23
Results Overview
TEAE was defined as an adverse event (AE) that was not present prior to the start date of study drug or was worsened during treatment and 100 days after last dose of treatment. An AE that was present at treatment initiation but resolved and then reappeared and the event severity increase while the participant was on treatment is also a TEAE. A severe AE (SAE) is defined as any untoward medical occurrence that at any dose: Is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, and is a congenital anomaly/birth defect. AEs were graded 1 (mild)-5 (fatal AE) according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Version 4.03.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
80 participants
Primary outcome timeframe
Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination
Results posted on
2025-01-23
Participant Flow
Participants with advanced solid tumours were recruited across 15 centers in Australia and South Korea from October 2018 to August 2021.
Participants received escalating doses of FTP155 until the recommended dose (RD) was established in Phase 1a monotherapy. Phase 1b monotherapy involved dividing participants into 4 tumor-specific cohorts, treated at the RD. In Phase 1a combination therapy, participants with non-small cell lung cancer were split into 3 cohorts and given FTP155 below the RD with Pembrolizumab. Both Phase 1b monotherapy and Phase 1a combination were initiated but not completed due to the study's closure.
Participant milestones
| Measure |
Phase 1a Monotherapy: FPT155 Dose A
Participants with advanced solid tumours received FPT155 intravenously (IV) once every 3 weeks (Q3W) in escalating doses (A-L) until the recommended dose (RD) was identified.
|
Phase 1a Monotherapy: FPT155 Dose B
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose C
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose D
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose E
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose F
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose G
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose H
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose I
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose J
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose K
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose L
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1b Monotherapy: 1bM1 FPT155 Dose K
Participants with advanced renal cell carcinoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM2 FPT155 Dose K
Participants with advanced melanoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM3 FPT155 Dose K
Participants with previously treated unresectable or metastatic non-small cell lung cancer and an absence of suitable standard treatment options were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM4 FPT155 Dose K
Participants with previously treated solid tumors with a response to prior PD-1 or PDL-1 directed treatment as defined by an objective response (partial or complete response) as determined by the Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1,or a minimum of 3 months on prior PD-1 or PDL-1 directed therapy were treated with FPT155 at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1a Combination: FPT155 (Dose H) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose H administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose I) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose I administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose J) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose J administered IV Q3W in combination with 200 mg Pembrolizumab.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
2
|
1
|
4
|
3
|
3
|
3
|
7
|
10
|
20
|
6
|
1
|
5
|
3
|
1
|
3
|
3
|
3
|
|
Overall Study
Received at Least 1 Dose of FPT155
|
1
|
1
|
2
|
1
|
4
|
3
|
3
|
3
|
7
|
10
|
20
|
6
|
1
|
5
|
3
|
1
|
3
|
3
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
2
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
2
|
1
|
4
|
3
|
3
|
3
|
5
|
8
|
20
|
5
|
1
|
5
|
3
|
1
|
3
|
3
|
3
|
Reasons for withdrawal
| Measure |
Phase 1a Monotherapy: FPT155 Dose A
Participants with advanced solid tumours received FPT155 intravenously (IV) once every 3 weeks (Q3W) in escalating doses (A-L) until the recommended dose (RD) was identified.
|
Phase 1a Monotherapy: FPT155 Dose B
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose C
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose D
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose E
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose F
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose G
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose H
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose I
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose J
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose K
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose L
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1b Monotherapy: 1bM1 FPT155 Dose K
Participants with advanced renal cell carcinoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM2 FPT155 Dose K
Participants with advanced melanoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM3 FPT155 Dose K
Participants with previously treated unresectable or metastatic non-small cell lung cancer and an absence of suitable standard treatment options were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM4 FPT155 Dose K
Participants with previously treated solid tumors with a response to prior PD-1 or PDL-1 directed treatment as defined by an objective response (partial or complete response) as determined by the Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1,or a minimum of 3 months on prior PD-1 or PDL-1 directed therapy were treated with FPT155 at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1a Combination: FPT155 (Dose H) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose H administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose I) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose I administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose J) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose J administered IV Q3W in combination with 200 mg Pembrolizumab.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
2
|
1
|
2
|
9
|
2
|
1
|
3
|
2
|
0
|
0
|
3
|
1
|
|
Overall Study
Death
|
1
|
0
|
1
|
1
|
2
|
0
|
1
|
0
|
3
|
2
|
4
|
1
|
0
|
2
|
1
|
0
|
1
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
|
Overall Study
Other
|
0
|
1
|
1
|
0
|
2
|
1
|
2
|
1
|
1
|
4
|
4
|
2
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Missing end of study status
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
FPT155 in Patients With Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
Phase 1a Monotherapy: FPT155 Dose A
n=1 Participants
Participants with advanced solid tumours received FPT155 intravenously (IV) once every 3 weeks (Q3W) in escalating doses (A-L) until the recommended dose (RD) was identified.
|
Phase 1a Monotherapy: FPT155 Dose B
n=1 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose C
n=2 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose D
n=1 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose E
n=4 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose F
n=3 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose G
n=3 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose H
n=3 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose I
n=7 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose J
n=10 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose K
n=20 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose L
n=6 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1b Monotherapy: 1bM1 FPT155 Dose K
n=1 Participants
Participants with advanced renal cell carcinoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM2 FPT155 Dose K
n=5 Participants
Participants with advanced melanoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM3 FPT155 Dose K
n=3 Participants
Participants with previously treated unresectable or metastatic non-small cell lung cancer and an absence of suitable standard treatment options were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM4 FPT155 Dose K
n=1 Participants
Participants with previously treated solid tumors with a response to prior PD-1 or PDL-1 directed treatment as defined by an objective response (partial or complete response) as determined by the Investigator per RECIST v1.1,or a minimum of 3 months on prior PD-1 or PDL-1 directed therapy were treated with FPT155 at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1a Combination: FPT155 (Dose H) + Pembrolizumab 200 mg
n=3 Participants
Participants with non-small cell lung cancer were treated with FTB155 Dose H administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose I) + Pembrolizumab 200 mg
n=3 Participants
Participants with non-small cell lung cancer were treated with FTB155 Dose I administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose J) + Pembrolizumab 200 mg
n=3 Participants
Participants with non-small cell lung cancer were treated with FTB155 Dose J administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
53 years
STANDARD_DEVIATION NA • n=99 Participants
|
61 years
STANDARD_DEVIATION NA • n=107 Participants
|
65.5 years
STANDARD_DEVIATION 10.61 • n=206 Participants
|
42 years
STANDARD_DEVIATION NA • n=7 Participants
|
63.5 years
STANDARD_DEVIATION 12.61 • n=31 Participants
|
64.3 years
STANDARD_DEVIATION 5.13 • n=30 Participants
|
69 years
STANDARD_DEVIATION 4.58 • n=3 Participants
|
53 years
STANDARD_DEVIATION 7.81 • n=6 Participants
|
57.3 years
STANDARD_DEVIATION 16.55 • n=114 Participants
|
58.6 years
STANDARD_DEVIATION 7.75
|
60.3 years
STANDARD_DEVIATION 12.17 • n=19 Participants
|
59.3 years
STANDARD_DEVIATION 14.22 • n=4 Participants
|
64 years
STANDARD_DEVIATION NA • n=7 Participants
|
53.4 years
STANDARD_DEVIATION 10.33 • n=7 Participants
|
64.7 years
STANDARD_DEVIATION 3.06 • n=3 Participants
|
71 years
STANDARD_DEVIATION NA • n=4 Participants
|
65.3 years
STANDARD_DEVIATION 3.06 • n=2 Participants
|
61.0 years
STANDARD_DEVIATION 15.13 • n=102 Participants
|
68.7 years
STANDARD_DEVIATION 2.52 • n=5 Participants
|
60.4 years
STANDARD_DEVIATION 10.95 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=114 Participants
|
5 Participants
|
5 Participants
n=19 Participants
|
5 Participants
n=4 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=2 Participants
|
0 Participants
n=102 Participants
|
1 Participants
n=5 Participants
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
4 Participants
n=114 Participants
|
5 Participants
|
15 Participants
n=19 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=2 Participants
|
3 Participants
n=102 Participants
|
2 Participants
n=5 Participants
|
42 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=114 Participants
|
4 Participants
|
12 Participants
n=19 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
3 Participants
n=102 Participants
|
1 Participants
n=5 Participants
|
33 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=114 Participants
|
5 Participants
|
7 Participants
n=19 Participants
|
5 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=2 Participants
|
0 Participants
n=102 Participants
|
2 Participants
n=5 Participants
|
43 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
1 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Missing
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
1 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
6 Participants
n=114 Participants
|
9 Participants
|
18 Participants
n=19 Participants
|
6 Participants
n=4 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=3 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=2 Participants
|
3 Participants
n=102 Participants
|
3 Participants
n=5 Participants
|
76 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
1 Participants
|
2 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a CombinationPopulation: Safety population: All participants who received any portion of a least one dose of FPT155.
TEAE was defined as an adverse event (AE) that was not present prior to the start date of study drug or was worsened during treatment and 100 days after last dose of treatment. An AE that was present at treatment initiation but resolved and then reappeared and the event severity increase while the participant was on treatment is also a TEAE. A severe AE (SAE) is defined as any untoward medical occurrence that at any dose: Is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, and is a congenital anomaly/birth defect. AEs were graded 1 (mild)-5 (fatal AE) according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Version 4.03.
Outcome measures
| Measure |
Phase 1a Monotherapy: FPT155 Dose A
n=1 Participants
Participants with advanced solid tumours received FPT155 intravenously (IV) once every 3 weeks (Q3W) in escalating doses (A-L) until the recommended dose (RD) was identified.
|
Phase 1a Monotherapy: FPT155 Dose B
n=1 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose C
n=2 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose D
n=1 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose E
n=4 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose F
n=3 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose G
n=3 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose H
n=3 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose I
n=7 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose J
n=10 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose K
n=20 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose L
n=6 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1b Monotherapy: 1bM1 FPT155 Dose K
n=1 Participants
Participants with advanced renal cell carcinoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM2 FPT155 Dose K
n=5 Participants
Participants with advanced melanoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM3 FPT155 Dose K
n=3 Participants
Participants with previously treated unresectable or metastatic non-small cell lung cancer and an absence of suitable standard treatment options were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM4 FPT155 Dose K
n=1 Participants
Participants with previously treated solid tumors with a response to prior PD-1 or PDL-1 directed treatment as defined by an objective response (partial or complete response) as determined by the Investigator per RECIST v1.1,or a minimum of 3 months on prior PD-1 or PDL-1 directed therapy were treated with FPT155 at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1a Combination: FPT155 (Dose H) + Pembrolizumab 200 mg
n=3 Participants
Participants with non-small cell lung cancer were treated with FTB155 Dose H administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose I) + Pembrolizumab 200 mg
n=3 Participants
Participants with non-small cell lung cancer were treated with FTB155 Dose I administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose J) + Pembrolizumab 200 mg
n=3 Participants
Participants with non-small cell lung cancer were treated with FTB155 Dose J administered IV Q3W in combination with 200 mg Pembrolizumab.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
All TEAEs
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
10 Participants
|
20 Participants
|
6 Participants
|
1 Participants
|
5 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
TEAEs Grade 3 or Higher
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
11 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
TEAEs Related to FPT155
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
6 Participants
|
11 Participants
|
6 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
All SAEs
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
10 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
SAEs Related to FPT155
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
TEAEs Leading to Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (one cycle = 21 days) Day 1 post-dose, up to approximately 21 daysPopulation: DLT-evaluable population: All participants enrolled into Phase 1a dose escalation portion of the study who received at least 1 dose of all assigned study drug(s) and remain on study for the 21-day DLT evaluation period, or who experienced a DLT before clearing the 21-day DLT evaluation interval. Study used a 3 + 3 design in the Phase 1a Monotherapy cohorts, from cohort "Phase 1a Monotherapy: FPT155 Dose E".
DLTs ware defined as any of the events that occurred during the first 28 days of treatment and were assessed by the Clinical Research Coordinator (CRC) as related to FPT155.
Outcome measures
| Measure |
Phase 1a Monotherapy: FPT155 Dose A
n=1 Participants
Participants with advanced solid tumours received FPT155 intravenously (IV) once every 3 weeks (Q3W) in escalating doses (A-L) until the recommended dose (RD) was identified.
|
Phase 1a Monotherapy: FPT155 Dose B
n=1 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose C
n=2 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose D
n=1 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose E
n=3 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose F
n=3 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose G
n=3 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose H
n=3 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose I
n=3 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose J
n=3 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose K
n=3 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose L
n=6 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1b Monotherapy: 1bM1 FPT155 Dose K
Participants with advanced renal cell carcinoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM2 FPT155 Dose K
Participants with advanced melanoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM3 FPT155 Dose K
Participants with previously treated unresectable or metastatic non-small cell lung cancer and an absence of suitable standard treatment options were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM4 FPT155 Dose K
Participants with previously treated solid tumors with a response to prior PD-1 or PDL-1 directed treatment as defined by an objective response (partial or complete response) as determined by the Investigator per RECIST v1.1,or a minimum of 3 months on prior PD-1 or PDL-1 directed therapy were treated with FPT155 at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1a Combination: FPT155 (Dose H) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose H administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose I) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose I administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose J) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose J administered IV Q3W in combination with 200 mg Pembrolizumab.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1a Monotherapy: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs)
All DLTs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1a Monotherapy: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs)
Cytokine release syndrome
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1a Monotherapy: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs)
Infusion related reaction
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Median (min, max) duration of FPT155 exposure was 8.29 [3.0, 27.1] weeks.Population: Safety population: All participants who received any portion of a least one dose of FPT155.
Represents the number of participants who had discontinuation of FPT155 dosing due to AEs.
Outcome measures
| Measure |
Phase 1a Monotherapy: FPT155 Dose A
n=1 Participants
Participants with advanced solid tumours received FPT155 intravenously (IV) once every 3 weeks (Q3W) in escalating doses (A-L) until the recommended dose (RD) was identified.
|
Phase 1a Monotherapy: FPT155 Dose B
n=5 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose C
n=3 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose D
n=1 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose E
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose F
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose G
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose H
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose I
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose J
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose K
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose L
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1b Monotherapy: 1bM1 FPT155 Dose K
Participants with advanced renal cell carcinoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM2 FPT155 Dose K
Participants with advanced melanoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM3 FPT155 Dose K
Participants with previously treated unresectable or metastatic non-small cell lung cancer and an absence of suitable standard treatment options were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM4 FPT155 Dose K
Participants with previously treated solid tumors with a response to prior PD-1 or PDL-1 directed treatment as defined by an objective response (partial or complete response) as determined by the Investigator per RECIST v1.1,or a minimum of 3 months on prior PD-1 or PDL-1 directed therapy were treated with FPT155 at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1a Combination: FPT155 (Dose H) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose H administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose I) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose I administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose J) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose J administered IV Q3W in combination with 200 mg Pembrolizumab.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1b Monotherapy: Number of Participants Who Had FPT155 Treatment Discontinued Due to AEs
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Median (min, max) duration of FPT155 exposure was 8.29 [3.0, 27.1] weeks.Population: Safety population: All participants who received any portion of a least one dose of FPT155.
Represents the number of participants who had a modification in the dosing schedules of FPT155 due to AEs.
Outcome measures
| Measure |
Phase 1a Monotherapy: FPT155 Dose A
n=1 Participants
Participants with advanced solid tumours received FPT155 intravenously (IV) once every 3 weeks (Q3W) in escalating doses (A-L) until the recommended dose (RD) was identified.
|
Phase 1a Monotherapy: FPT155 Dose B
n=5 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose C
n=3 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose D
n=1 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose E
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose F
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose G
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose H
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose I
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose J
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose K
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose L
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1b Monotherapy: 1bM1 FPT155 Dose K
Participants with advanced renal cell carcinoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM2 FPT155 Dose K
Participants with advanced melanoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM3 FPT155 Dose K
Participants with previously treated unresectable or metastatic non-small cell lung cancer and an absence of suitable standard treatment options were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM4 FPT155 Dose K
Participants with previously treated solid tumors with a response to prior PD-1 or PDL-1 directed treatment as defined by an objective response (partial or complete response) as determined by the Investigator per RECIST v1.1,or a minimum of 3 months on prior PD-1 or PDL-1 directed therapy were treated with FPT155 at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1a Combination: FPT155 (Dose H) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose H administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose I) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose I administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose J) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose J administered IV Q3W in combination with 200 mg Pembrolizumab.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1b Monotherapy: Number of Participants Who Had FPT155 Treatment Modified Due to AEs
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Median (min, max) duration of FPT155 exposure was 8.29 [3.0, 27.1] weeks.Population: Safety population: All participants who received any portion of a least one dose of FPT155.
Represents the number of participants who had an interruption in the dosing schedules of FPT155 due to AEs.
Outcome measures
| Measure |
Phase 1a Monotherapy: FPT155 Dose A
n=1 Participants
Participants with advanced solid tumours received FPT155 intravenously (IV) once every 3 weeks (Q3W) in escalating doses (A-L) until the recommended dose (RD) was identified.
|
Phase 1a Monotherapy: FPT155 Dose B
n=5 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose C
n=3 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose D
n=1 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose E
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose F
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose G
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose H
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose I
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose J
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose K
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose L
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1b Monotherapy: 1bM1 FPT155 Dose K
Participants with advanced renal cell carcinoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM2 FPT155 Dose K
Participants with advanced melanoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM3 FPT155 Dose K
Participants with previously treated unresectable or metastatic non-small cell lung cancer and an absence of suitable standard treatment options were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM4 FPT155 Dose K
Participants with previously treated solid tumors with a response to prior PD-1 or PDL-1 directed treatment as defined by an objective response (partial or complete response) as determined by the Investigator per RECIST v1.1,or a minimum of 3 months on prior PD-1 or PDL-1 directed therapy were treated with FPT155 at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1a Combination: FPT155 (Dose H) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose H administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose I) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose I administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose J) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose J administered IV Q3W in combination with 200 mg Pembrolizumab.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1b Monotherapy: Number of Participants Who Had FPT155 Treatment Interrupted Due to AEs
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Cycle 1 (one cycle = 21 days) Day 1 post-dose, up to approximately 21 daysPopulation: DLT-evaluable population: All participants enrolled into Phase 1a dose escalation portion of the study who received at least 1 dose of all assigned study drug(s) and remain on study for the 21-day DLT evaluation period, or who experienced a DLT before clearing the 21-day DLT evaluation interval.
DLTs ware defined as any of the events that occur during the first 28 days of treatment and are assessed by the CRC as related to FPT155.
Outcome measures
| Measure |
Phase 1a Monotherapy: FPT155 Dose A
n=3 Participants
Participants with advanced solid tumours received FPT155 intravenously (IV) once every 3 weeks (Q3W) in escalating doses (A-L) until the recommended dose (RD) was identified.
|
Phase 1a Monotherapy: FPT155 Dose B
n=3 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose C
n=3 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose D
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose E
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose F
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose G
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose H
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose I
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose J
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose K
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose L
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1b Monotherapy: 1bM1 FPT155 Dose K
Participants with advanced renal cell carcinoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM2 FPT155 Dose K
Participants with advanced melanoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM3 FPT155 Dose K
Participants with previously treated unresectable or metastatic non-small cell lung cancer and an absence of suitable standard treatment options were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM4 FPT155 Dose K
Participants with previously treated solid tumors with a response to prior PD-1 or PDL-1 directed treatment as defined by an objective response (partial or complete response) as determined by the Investigator per RECIST v1.1,or a minimum of 3 months on prior PD-1 or PDL-1 directed therapy were treated with FPT155 at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1a Combination: FPT155 (Dose H) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose H administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose I) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose I administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose J) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose J administered IV Q3W in combination with 200 mg Pembrolizumab.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1a Combination: Number of Participants Who Experienced DLTs
All DLTs
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1a Combination: Number of Participants Who Experienced DLTs
Cytokine release syndrome
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1a Combination: Number of Participants Who Experienced DLTs
Aspartate aminotransferase increased
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15Population: PK-Evaluable Population: All participants who received at least one dose of study drug, and had sufficient PK sample for the calculation of at least one PK parameter on at least one Study Day, and had evaluable data.
Outcome measures
| Measure |
Phase 1a Monotherapy: FPT155 Dose A
n=1 Participants
Participants with advanced solid tumours received FPT155 intravenously (IV) once every 3 weeks (Q3W) in escalating doses (A-L) until the recommended dose (RD) was identified.
|
Phase 1a Monotherapy: FPT155 Dose B
n=1 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose C
n=2 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose D
n=1 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose E
n=4 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose F
n=3 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose G
n=3 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose H
n=3 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose I
n=7 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose J
n=10 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose K
n=16 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose L
n=2 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1b Monotherapy: 1bM1 FPT155 Dose K
Participants with advanced renal cell carcinoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM2 FPT155 Dose K
Participants with advanced melanoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM3 FPT155 Dose K
Participants with previously treated unresectable or metastatic non-small cell lung cancer and an absence of suitable standard treatment options were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM4 FPT155 Dose K
Participants with previously treated solid tumors with a response to prior PD-1 or PDL-1 directed treatment as defined by an objective response (partial or complete response) as determined by the Investigator per RECIST v1.1,or a minimum of 3 months on prior PD-1 or PDL-1 directed therapy were treated with FPT155 at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1a Combination: FPT155 (Dose H) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose H administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose I) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose I administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose J) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose J administered IV Q3W in combination with 200 mg Pembrolizumab.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1a Monotherapy: Area Under Serum Concentration-time Profile From Time 0 to Time Tau (The Dosing Interval) (AUC0-tau) of FPT155
|
0.0327 day*ug/mL
Standard Deviation NA
Value not estimable as only 1 participant was in the arm.
|
0.1586 day*ug/mL
Standard Deviation NA
Value not estimable as only 1 participant was in the arm.
|
1.1365 day*ug/mL
Standard Deviation 0.36220
|
2.4057 day*ug/mL
Standard Deviation NA
Value not estimable as only 1 participant was in the arm.
|
7.6030 day*ug/mL
Standard Deviation 1.70572
|
20.9191 day*ug/mL
Standard Deviation 2.58340
|
38.4803 day*ug/mL
Standard Deviation 5.39054
|
73.3365 day*ug/mL
Standard Deviation 20.47867
|
165.9985 day*ug/mL
Standard Deviation 38.97415
|
318.4115 day*ug/mL
Standard Deviation 55.46423
|
680.4735 day*ug/mL
Standard Deviation 186.74665
|
578.2617 day*ug/mL
Standard Deviation 411.33336
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15Population: PK-Evaluable Population: All participants who received at least one dose of study drug, and had sufficient PK sample for the calculation of at least one PK parameter on at least one Study Day, and had evaluable data.
Outcome measures
| Measure |
Phase 1a Monotherapy: FPT155 Dose A
n=1 Participants
Participants with advanced solid tumours received FPT155 intravenously (IV) once every 3 weeks (Q3W) in escalating doses (A-L) until the recommended dose (RD) was identified.
|
Phase 1a Monotherapy: FPT155 Dose B
n=1 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose C
n=2 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose D
n=1 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose E
n=4 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose F
n=3 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose G
n=3 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose H
n=3 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose I
n=7 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose J
n=10 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose K
n=17 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose L
n=2 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1b Monotherapy: 1bM1 FPT155 Dose K
Participants with advanced renal cell carcinoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM2 FPT155 Dose K
Participants with advanced melanoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM3 FPT155 Dose K
Participants with previously treated unresectable or metastatic non-small cell lung cancer and an absence of suitable standard treatment options were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM4 FPT155 Dose K
Participants with previously treated solid tumors with a response to prior PD-1 or PDL-1 directed treatment as defined by an objective response (partial or complete response) as determined by the Investigator per RECIST v1.1,or a minimum of 3 months on prior PD-1 or PDL-1 directed therapy were treated with FPT155 at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1a Combination: FPT155 (Dose H) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose H administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose I) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose I administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose J) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose J administered IV Q3W in combination with 200 mg Pembrolizumab.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1a Monotherapy: Maximum Observed Serum Concentration (Cmax) of FPT155
|
0.0152 ug/mL
Standard Deviation NA
Value not estimable as only 1 participant was in the arm.
|
0.0398 ug/mL
Standard Deviation NA
Value not estimable as only 1 participant was in the arm.
|
0.3185 ug/mL
Standard Deviation 0.19304
|
0.4440 ug/mL
Standard Deviation NA
Value not estimable as only 1 participant was in the arm.
|
1.7033 ug/mL
Standard Deviation 0.37909
|
4.1403 ug/mL
Standard Deviation 1.00748
|
8.2337 ug/mL
Standard Deviation 0.99910
|
15.0070 ug/mL
Standard Deviation 1.67983
|
42.4436 ug/mL
Standard Deviation 14.15113
|
74.4304 ug/mL
Standard Deviation 12.04634
|
154.4599 ug/mL
Standard Deviation 36.68364
|
236.0270 ug/mL
Standard Deviation 91.32991
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15Population: PK-Evaluable Population: All participants who received at least one dose of study drug, and had sufficient PK sample for the calculation of at least one PK parameter on at least one Study Day, and had evaluable data.
Outcome measures
| Measure |
Phase 1a Monotherapy: FPT155 Dose A
Participants with advanced solid tumours received FPT155 intravenously (IV) once every 3 weeks (Q3W) in escalating doses (A-L) until the recommended dose (RD) was identified.
|
Phase 1a Monotherapy: FPT155 Dose B
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose C
n=1 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose D
n=1 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose E
n=4 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose F
n=3 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose G
n=3 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose H
n=3 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose I
n=7 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose J
n=9 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose K
n=12 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose L
n=1 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1b Monotherapy: 1bM1 FPT155 Dose K
Participants with advanced renal cell carcinoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM2 FPT155 Dose K
Participants with advanced melanoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM3 FPT155 Dose K
Participants with previously treated unresectable or metastatic non-small cell lung cancer and an absence of suitable standard treatment options were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM4 FPT155 Dose K
Participants with previously treated solid tumors with a response to prior PD-1 or PDL-1 directed treatment as defined by an objective response (partial or complete response) as determined by the Investigator per RECIST v1.1,or a minimum of 3 months on prior PD-1 or PDL-1 directed therapy were treated with FPT155 at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1a Combination: FPT155 (Dose H) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose H administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose I) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose I administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose J) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose J administered IV Q3W in combination with 200 mg Pembrolizumab.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1a Monotherapy: Trough Observed Serum Concentration at the End of Each Dose Interval (Ctrough) of FPT155
|
—
|
—
|
0.0097 ug/mL
Standard Deviation NA
Value not estimable as only 1 participant was in the arm.
|
0.0211 ug/mL
Standard Deviation NA
Value not estimable as only 1 participant was in the arm.
|
0.0670 ug/mL
Standard Deviation 0.03697
|
0.2827 ug/mL
Standard Deviation 0.02203
|
0.2793 ug/mL
Standard Deviation 0.02875
|
0.9813 ug/mL
Standard Deviation 0.72419
|
1.8921 ug/mL
Standard Deviation 0.97118
|
3.0308 ug/mL
Standard Deviation 0.97789
|
8.1734 ug/mL
Standard Deviation 3.79640
|
8.0930 ug/mL
Standard Deviation NA
Value not estimable as only 1 participant was in the arm.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15Population: PK-Evaluable Population: All participants who received at least one dose of study drug, and had sufficient PK sample for the calculation of at least one PK parameter on at least one Study Day, and had evaluable data.
Outcome measures
| Measure |
Phase 1a Monotherapy: FPT155 Dose A
Participants with advanced solid tumours received FPT155 intravenously (IV) once every 3 weeks (Q3W) in escalating doses (A-L) until the recommended dose (RD) was identified.
|
Phase 1a Monotherapy: FPT155 Dose B
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose C
n=1 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose D
n=1 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose E
n=4 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose F
n=3 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose G
n=3 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose H
n=3 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose I
n=7 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose J
n=10 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose K
n=13 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose L
n=1 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1b Monotherapy: 1bM1 FPT155 Dose K
Participants with advanced renal cell carcinoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM2 FPT155 Dose K
Participants with advanced melanoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM3 FPT155 Dose K
Participants with previously treated unresectable or metastatic non-small cell lung cancer and an absence of suitable standard treatment options were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM4 FPT155 Dose K
Participants with previously treated solid tumors with a response to prior PD-1 or PDL-1 directed treatment as defined by an objective response (partial or complete response) as determined by the Investigator per RECIST v1.1,or a minimum of 3 months on prior PD-1 or PDL-1 directed therapy were treated with FPT155 at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1a Combination: FPT155 (Dose H) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose H administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose I) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose I administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose J) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose J administered IV Q3W in combination with 200 mg Pembrolizumab.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1a Monotherapy: Clearance (CL) of FPT155
|
—
|
—
|
723.1295 mL/day
Standard Deviation NA
Value not estimable as only 1 participant was in the arm.
|
816.5143 mL/day
Standard Deviation NA
Value not estimable as only 1 participant was in the arm.
|
872.7624 mL/day
Standard Deviation 177.16607
|
885.2506 mL/day
Standard Deviation 121.93486
|
1023.0799 mL/day
Standard Deviation 117.05581
|
921.2589 mL/day
Standard Deviation 387.65387
|
803.7378 mL/day
Standard Deviation 247.88188
|
838.7004 mL/day
Standard Deviation 152.86047
|
822.2251 mL/day
Standard Deviation 308.79493
|
893.7646 mL/day
Standard Deviation NA
Value not estimable as only 1 participant was in the arm.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15Population: PK-Evaluable Population: All participants who received at least one dose of study drug, and had sufficient PK sample for the calculation of at least one PK parameter on at least one Study Day, and had evaluable data.
Outcome measures
| Measure |
Phase 1a Monotherapy: FPT155 Dose A
Participants with advanced solid tumours received FPT155 intravenously (IV) once every 3 weeks (Q3W) in escalating doses (A-L) until the recommended dose (RD) was identified.
|
Phase 1a Monotherapy: FPT155 Dose B
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose C
n=1 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose D
n=1 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose E
n=4 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose F
n=3 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose G
n=3 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose H
n=3 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose I
n=7 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose J
n=10 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose K
n=13 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose L
n=1 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1b Monotherapy: 1bM1 FPT155 Dose K
Participants with advanced renal cell carcinoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM2 FPT155 Dose K
Participants with advanced melanoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM3 FPT155 Dose K
Participants with previously treated unresectable or metastatic non-small cell lung cancer and an absence of suitable standard treatment options were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM4 FPT155 Dose K
Participants with previously treated solid tumors with a response to prior PD-1 or PDL-1 directed treatment as defined by an objective response (partial or complete response) as determined by the Investigator per RECIST v1.1,or a minimum of 3 months on prior PD-1 or PDL-1 directed therapy were treated with FPT155 at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1a Combination: FPT155 (Dose H) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose H administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose I) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose I administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose J) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose J administered IV Q3W in combination with 200 mg Pembrolizumab.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1a Monotherapy: Terminal Half-life (t1/2) of FPT155
|
—
|
—
|
6.2328 hours
Standard Deviation NA
Value not estimable as only 1 participant was in the arm.
|
5.5142 hours
Standard Deviation NA
Value not estimable as only 1 participant was in the arm.
|
6.2067 hours
Standard Deviation 0.61062
|
7.5696 hours
Standard Deviation 0.69887
|
5.3969 hours
Standard Deviation 0.40483
|
6.7752 hours
Standard Deviation 2.32987
|
6.9751 hours
Standard Deviation 1.62270
|
5.8128 hours
Standard Deviation 0.80921
|
5.9846 hours
Standard Deviation 1.27669
|
5.3674 hours
Standard Deviation NA
Value not estimable as only 1 participant was in the arm.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15Population: PK-Evaluable Population: All participants who received at least one dose of study drug, and had sufficient PK sample for the calculation of at least one PK parameter on at least one Study Day, and had evaluable data.
Outcome measures
| Measure |
Phase 1a Monotherapy: FPT155 Dose A
Participants with advanced solid tumours received FPT155 intravenously (IV) once every 3 weeks (Q3W) in escalating doses (A-L) until the recommended dose (RD) was identified.
|
Phase 1a Monotherapy: FPT155 Dose B
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose C
n=1 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose D
n=1 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose E
n=4 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose F
n=3 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose G
n=3 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose H
n=3 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose I
n=7 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose J
n=10 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose K
n=13 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose L
n=1 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1b Monotherapy: 1bM1 FPT155 Dose K
Participants with advanced renal cell carcinoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM2 FPT155 Dose K
Participants with advanced melanoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM3 FPT155 Dose K
Participants with previously treated unresectable or metastatic non-small cell lung cancer and an absence of suitable standard treatment options were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM4 FPT155 Dose K
Participants with previously treated solid tumors with a response to prior PD-1 or PDL-1 directed treatment as defined by an objective response (partial or complete response) as determined by the Investigator per RECIST v1.1,or a minimum of 3 months on prior PD-1 or PDL-1 directed therapy were treated with FPT155 at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1a Combination: FPT155 (Dose H) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose H administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose I) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose I administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose J) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose J administered IV Q3W in combination with 200 mg Pembrolizumab.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1a Monotherapy: Volume of Distribution at Steady State (Vss) of FPT155
|
—
|
—
|
5589.3077 mL
Standard Deviation NA
Value not estimable as only 1 participant was in the arm.
|
5945.0963 mL
Standard Deviation NA
Value not estimable as only 1 participant was in the arm.
|
6390.4335 mL
Standard Deviation 974.58304
|
8258.2000 mL
Standard Deviation 1221.67174
|
7073.7877 mL
Standard Deviation 1555.88613
|
6994.1331 mL
Standard Deviation 672.03487
|
6413.4280 mL
Standard Deviation 1007.47809
|
5958.4609 mL
Standard Deviation 1409.10784
|
5945.5205 mL
Standard Deviation 1442.85088
|
6032.9646 mL
Standard Deviation NA
Value not estimable as only 1 participant was in the arm.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 (21-day cycles) Day 1Population: Safety population: All participants who received any portion of a least one dose of FPT155.
Data presented below includes participants with at least 1 anti-drug antibodies-positive sample relative to baseline after initiation of the treatment.
Outcome measures
| Measure |
Phase 1a Monotherapy: FPT155 Dose A
n=1 Participants
Participants with advanced solid tumours received FPT155 intravenously (IV) once every 3 weeks (Q3W) in escalating doses (A-L) until the recommended dose (RD) was identified.
|
Phase 1a Monotherapy: FPT155 Dose B
n=1 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose C
n=2 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose D
n=1 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose E
n=4 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose F
n=3 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose G
n=3 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose H
n=3 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose I
n=7 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose J
n=10 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose K
n=20 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose L
n=6 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1b Monotherapy: 1bM1 FPT155 Dose K
Participants with advanced renal cell carcinoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM2 FPT155 Dose K
Participants with advanced melanoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM3 FPT155 Dose K
Participants with previously treated unresectable or metastatic non-small cell lung cancer and an absence of suitable standard treatment options were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM4 FPT155 Dose K
Participants with previously treated solid tumors with a response to prior PD-1 or PDL-1 directed treatment as defined by an objective response (partial or complete response) as determined by the Investigator per RECIST v1.1,or a minimum of 3 months on prior PD-1 or PDL-1 directed therapy were treated with FPT155 at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1a Combination: FPT155 (Dose H) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose H administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose I) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose I administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose J) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose J administered IV Q3W in combination with 200 mg Pembrolizumab.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1a Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response
Anti-FPT155 Positive
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1a Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response
Anti-FPT155 Negative
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
8 Participants
|
9 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1a Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response
Not Evaluable
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
8 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 30 monthsPopulation: Efficacy Population: All participants who received any portion of at least one dose of FPT155.
ORR was defined as the total number of participants with confirmed responses of either complete response (CR) (CR: The disappearance of all target lesions, any pathological lymph nodes \[whether target or non-target\] must have a reduction in short axis to \<10 mm) or partial response (PR) (PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters), as determined by the investigator per RECIST v1.1.
Outcome measures
| Measure |
Phase 1a Monotherapy: FPT155 Dose A
n=1 Participants
Participants with advanced solid tumours received FPT155 intravenously (IV) once every 3 weeks (Q3W) in escalating doses (A-L) until the recommended dose (RD) was identified.
|
Phase 1a Monotherapy: FPT155 Dose B
n=5 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose C
n=3 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose D
n=1 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose E
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose F
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose G
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose H
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose I
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose J
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose K
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose L
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1b Monotherapy: 1bM1 FPT155 Dose K
Participants with advanced renal cell carcinoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM2 FPT155 Dose K
Participants with advanced melanoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM3 FPT155 Dose K
Participants with previously treated unresectable or metastatic non-small cell lung cancer and an absence of suitable standard treatment options were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM4 FPT155 Dose K
Participants with previously treated solid tumors with a response to prior PD-1 or PDL-1 directed treatment as defined by an objective response (partial or complete response) as determined by the Investigator per RECIST v1.1,or a minimum of 3 months on prior PD-1 or PDL-1 directed therapy were treated with FPT155 at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1a Combination: FPT155 (Dose H) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose H administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose I) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose I administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose J) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose J administered IV Q3W in combination with 200 mg Pembrolizumab.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1b Monotherapy: Objective Response Rate (ORR) Per RECIST v1.1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 30 monthsPopulation: Efficacy population inclusive of participants with CR or PR.
DOR was defined as the time from first response (CR \[The disappearance of all target lesions, any pathological lymph nodes {whether target or non-target} or PR \[At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters\] determined by the investigator per RECIST v1.1) that was subsequently confirmed until the onset of progressive disease (DP) (DP: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study \[this includes the baseline sum if that is the smallest on study\]. In addition to the 20% relative increase, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression) or death from any cause, whichever occurred first.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 30 monthsPopulation: Efficacy Population: All participants who received any portion of at least one dose of FPT155.
PFS was defined as time from the first dose of study treatment until the first documentation by the investigator of DP (DP: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study \[this includes the baseline sum if that is the smallest on study\]. In addition to the 20% relative increase, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression) per RECIST v1.1 or death from any cause, whichever occurred first. The median was estimated by using the Kaplan-Meier method and corresponding 2-sided 90% CI using Brookmeyer and Crowley methodology.
Outcome measures
| Measure |
Phase 1a Monotherapy: FPT155 Dose A
n=1 Participants
Participants with advanced solid tumours received FPT155 intravenously (IV) once every 3 weeks (Q3W) in escalating doses (A-L) until the recommended dose (RD) was identified.
|
Phase 1a Monotherapy: FPT155 Dose B
n=5 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose C
n=3 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose D
n=1 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose E
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose F
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose G
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose H
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose I
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose J
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose K
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose L
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1b Monotherapy: 1bM1 FPT155 Dose K
Participants with advanced renal cell carcinoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM2 FPT155 Dose K
Participants with advanced melanoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM3 FPT155 Dose K
Participants with previously treated unresectable or metastatic non-small cell lung cancer and an absence of suitable standard treatment options were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM4 FPT155 Dose K
Participants with previously treated solid tumors with a response to prior PD-1 or PDL-1 directed treatment as defined by an objective response (partial or complete response) as determined by the Investigator per RECIST v1.1,or a minimum of 3 months on prior PD-1 or PDL-1 directed therapy were treated with FPT155 at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1a Combination: FPT155 (Dose H) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose H administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose I) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose I administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose J) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose J administered IV Q3W in combination with 200 mg Pembrolizumab.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1b Monotherapy: Progression-free Survival (PFS) Per RECIST v1.1
|
1.31 months
Due to the low number of participants (1) there are too few observations (1) that impacted the estimate of the survival function to no variation, hence the 90% CIs could not be estimated.
|
1.38 months
Interval 0.72 to 5.42
|
4.01 months
Interval 1.18 to
Upper CI could not be calculated due to the low number of observations.
|
1.41 months
Due to the low number of participants (1) there are too few observations (1) that impacted the estimate of the survival function to no variation, hence the 90% CIs could not be estimated.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 30 monthsPopulation: Efficacy Population: All participants who received any portion of at least one dose of FPT155.
DCR was defined as the total number of participants with confirmed responses of either CR (CR: The disappearance of all target lesions, any pathological lymph nodes \[whether target or non-target\] must have a reduction in short axis to \<10 mm), PR (PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters), or stable disease (SD) (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. In numerical terms, it means a reduction in tumor size that is less than 30% \[which is required for PR\] and an increase in size that is less than 20% \[which is required for PD\]) as determined by the investigator per RECIST v1.1.
Outcome measures
| Measure |
Phase 1a Monotherapy: FPT155 Dose A
n=1 Participants
Participants with advanced solid tumours received FPT155 intravenously (IV) once every 3 weeks (Q3W) in escalating doses (A-L) until the recommended dose (RD) was identified.
|
Phase 1a Monotherapy: FPT155 Dose B
n=5 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose C
n=3 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose D
n=1 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose E
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose F
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose G
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose H
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose I
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose J
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose K
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose L
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1b Monotherapy: 1bM1 FPT155 Dose K
Participants with advanced renal cell carcinoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM2 FPT155 Dose K
Participants with advanced melanoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM3 FPT155 Dose K
Participants with previously treated unresectable or metastatic non-small cell lung cancer and an absence of suitable standard treatment options were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM4 FPT155 Dose K
Participants with previously treated solid tumors with a response to prior PD-1 or PDL-1 directed treatment as defined by an objective response (partial or complete response) as determined by the Investigator per RECIST v1.1,or a minimum of 3 months on prior PD-1 or PDL-1 directed therapy were treated with FPT155 at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1a Combination: FPT155 (Dose H) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose H administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose I) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose I administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose J) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose J administered IV Q3W in combination with 200 mg Pembrolizumab.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1b Monotherapy: Disease Control Rate (DCR) Per RECIST v1.1
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15Population: PK-Evaluable Population: All participants who received at least one dose of study drug, and had sufficient PK sample for the calculation of at least one PK parameter on at least one Study Day, and had evaluable data.
Outcome measures
| Measure |
Phase 1a Monotherapy: FPT155 Dose A
n=1 Participants
Participants with advanced solid tumours received FPT155 intravenously (IV) once every 3 weeks (Q3W) in escalating doses (A-L) until the recommended dose (RD) was identified.
|
Phase 1a Monotherapy: FPT155 Dose B
n=4 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose C
n=3 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose D
n=1 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose E
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose F
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose G
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose H
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose I
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose J
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose K
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose L
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1b Monotherapy: 1bM1 FPT155 Dose K
Participants with advanced renal cell carcinoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM2 FPT155 Dose K
Participants with advanced melanoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM3 FPT155 Dose K
Participants with previously treated unresectable or metastatic non-small cell lung cancer and an absence of suitable standard treatment options were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM4 FPT155 Dose K
Participants with previously treated solid tumors with a response to prior PD-1 or PDL-1 directed treatment as defined by an objective response (partial or complete response) as determined by the Investigator per RECIST v1.1,or a minimum of 3 months on prior PD-1 or PDL-1 directed therapy were treated with FPT155 at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1a Combination: FPT155 (Dose H) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose H administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose I) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose I administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose J) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose J administered IV Q3W in combination with 200 mg Pembrolizumab.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1b Monotherapy: AUC0-tau of FPT155
|
785.6775 day*ug/mL
Standard Deviation NA
Value not estimable as only 1 participant was in the arm.
|
874.0402 day*ug/mL
Standard Deviation 236.97475
|
827.3523 day*ug/mL
Standard Deviation 314.06602
|
245.5924 day*ug/mL
Standard Deviation NA
Value not estimable as only 1 participant was in the arm.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15Population: PK-Evaluable Population: All participants who received at least one dose of study drug, and had sufficient PK sample for the calculation of at least one PK parameter on at least one Study Day, and had evaluable data.
Outcome measures
| Measure |
Phase 1a Monotherapy: FPT155 Dose A
n=1 Participants
Participants with advanced solid tumours received FPT155 intravenously (IV) once every 3 weeks (Q3W) in escalating doses (A-L) until the recommended dose (RD) was identified.
|
Phase 1a Monotherapy: FPT155 Dose B
n=4 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose C
n=3 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose D
n=1 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose E
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose F
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose G
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose H
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose I
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose J
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose K
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose L
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1b Monotherapy: 1bM1 FPT155 Dose K
Participants with advanced renal cell carcinoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM2 FPT155 Dose K
Participants with advanced melanoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM3 FPT155 Dose K
Participants with previously treated unresectable or metastatic non-small cell lung cancer and an absence of suitable standard treatment options were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM4 FPT155 Dose K
Participants with previously treated solid tumors with a response to prior PD-1 or PDL-1 directed treatment as defined by an objective response (partial or complete response) as determined by the Investigator per RECIST v1.1,or a minimum of 3 months on prior PD-1 or PDL-1 directed therapy were treated with FPT155 at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1a Combination: FPT155 (Dose H) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose H administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose I) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose I administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose J) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose J administered IV Q3W in combination with 200 mg Pembrolizumab.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1b Monotherapy: Cmax of FPT155
|
203.4790 ug/mL
Standard Deviation NA
Value not estimable as only 1 participant was in the arm.
|
180.9630 ug/mL
Standard Deviation 51.85915
|
214.5727 ug/mL
Standard Deviation 86.57029
|
178.5870 ug/mL
Standard Deviation NA
Value not estimable as only 1 participant was in the arm.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15Population: PK-Evaluable Population: All participants who received at least one dose of study drug, and had sufficient PK sample for the calculation of at least one PK parameter on at least one Study Day, and had evaluable data.
Outcome measures
| Measure |
Phase 1a Monotherapy: FPT155 Dose A
n=1 Participants
Participants with advanced solid tumours received FPT155 intravenously (IV) once every 3 weeks (Q3W) in escalating doses (A-L) until the recommended dose (RD) was identified.
|
Phase 1a Monotherapy: FPT155 Dose B
n=2 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose C
n=2 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose D
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose E
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose F
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose G
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose H
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose I
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose J
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose K
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose L
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1b Monotherapy: 1bM1 FPT155 Dose K
Participants with advanced renal cell carcinoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM2 FPT155 Dose K
Participants with advanced melanoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM3 FPT155 Dose K
Participants with previously treated unresectable or metastatic non-small cell lung cancer and an absence of suitable standard treatment options were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM4 FPT155 Dose K
Participants with previously treated solid tumors with a response to prior PD-1 or PDL-1 directed treatment as defined by an objective response (partial or complete response) as determined by the Investigator per RECIST v1.1,or a minimum of 3 months on prior PD-1 or PDL-1 directed therapy were treated with FPT155 at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1a Combination: FPT155 (Dose H) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose H administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose I) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose I administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose J) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose J administered IV Q3W in combination with 200 mg Pembrolizumab.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1b Monotherapy: Ctrough of FPT155
|
1.2920 ug/mL
Standard Deviation NA
Value not estimable as only 1 participant was in the arm.
|
11.6875 ug/mL
Standard Deviation 0.77428
|
5.5480 ug/mL
Standard Deviation 0.58266
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15Population: PK-Evaluable Population: All participants who received at least one dose of study drug, and had sufficient PK sample for the calculation of at least one PK parameter on at least one Study Day, and had evaluable data.
Outcome measures
| Measure |
Phase 1a Monotherapy: FPT155 Dose A
n=1 Participants
Participants with advanced solid tumours received FPT155 intravenously (IV) once every 3 weeks (Q3W) in escalating doses (A-L) until the recommended dose (RD) was identified.
|
Phase 1a Monotherapy: FPT155 Dose B
n=3 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose C
n=3 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose D
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose E
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose F
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose G
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose H
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose I
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose J
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose K
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose L
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1b Monotherapy: 1bM1 FPT155 Dose K
Participants with advanced renal cell carcinoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM2 FPT155 Dose K
Participants with advanced melanoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM3 FPT155 Dose K
Participants with previously treated unresectable or metastatic non-small cell lung cancer and an absence of suitable standard treatment options were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM4 FPT155 Dose K
Participants with previously treated solid tumors with a response to prior PD-1 or PDL-1 directed treatment as defined by an objective response (partial or complete response) as determined by the Investigator per RECIST v1.1,or a minimum of 3 months on prior PD-1 or PDL-1 directed therapy were treated with FPT155 at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1a Combination: FPT155 (Dose H) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose H administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose I) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose I administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose J) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose J administered IV Q3W in combination with 200 mg Pembrolizumab.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1b Monotherapy: CL of FPT155
|
662.0429 mL/day
Standard Deviation NA
Value not estimable as only 1 participant was in the arm.
|
555.8419 mL/day
Standard Deviation 119.27137
|
698.3282 mL/day
Standard Deviation 278.39932
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15Population: PK-Evaluable Population: All participants who received at least one dose of study drug, and had sufficient PK sample for the calculation of at least one PK parameter on at least one Study Day, and had evaluable data.
Outcome measures
| Measure |
Phase 1a Monotherapy: FPT155 Dose A
n=1 Participants
Participants with advanced solid tumours received FPT155 intravenously (IV) once every 3 weeks (Q3W) in escalating doses (A-L) until the recommended dose (RD) was identified.
|
Phase 1a Monotherapy: FPT155 Dose B
n=3 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose C
n=3 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose D
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose E
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose F
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose G
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose H
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose I
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose J
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose K
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose L
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1b Monotherapy: 1bM1 FPT155 Dose K
Participants with advanced renal cell carcinoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM2 FPT155 Dose K
Participants with advanced melanoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM3 FPT155 Dose K
Participants with previously treated unresectable or metastatic non-small cell lung cancer and an absence of suitable standard treatment options were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM4 FPT155 Dose K
Participants with previously treated solid tumors with a response to prior PD-1 or PDL-1 directed treatment as defined by an objective response (partial or complete response) as determined by the Investigator per RECIST v1.1,or a minimum of 3 months on prior PD-1 or PDL-1 directed therapy were treated with FPT155 at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1a Combination: FPT155 (Dose H) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose H administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose I) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose I administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose J) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose J administered IV Q3W in combination with 200 mg Pembrolizumab.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1b Monotherapy: t1/2 of FPT155
|
5.7318 day
Standard Deviation NA
Value not estimable as only 1 participant was in the arm.
|
6.9369 day
Standard Deviation 1.38733
|
5.7844 day
Standard Deviation 0.33807
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15Population: PK-Evaluable Population: All participants who received at least one dose of study drug, and had sufficient PK sample for the calculation of at least one PK parameter on at least one Study Day, and had evaluable data.
Outcome measures
| Measure |
Phase 1a Monotherapy: FPT155 Dose A
n=1 Participants
Participants with advanced solid tumours received FPT155 intravenously (IV) once every 3 weeks (Q3W) in escalating doses (A-L) until the recommended dose (RD) was identified.
|
Phase 1a Monotherapy: FPT155 Dose B
n=3 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose C
n=3 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose D
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose E
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose F
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose G
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose H
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose I
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose J
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose K
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose L
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1b Monotherapy: 1bM1 FPT155 Dose K
Participants with advanced renal cell carcinoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM2 FPT155 Dose K
Participants with advanced melanoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM3 FPT155 Dose K
Participants with previously treated unresectable or metastatic non-small cell lung cancer and an absence of suitable standard treatment options were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM4 FPT155 Dose K
Participants with previously treated solid tumors with a response to prior PD-1 or PDL-1 directed treatment as defined by an objective response (partial or complete response) as determined by the Investigator per RECIST v1.1,or a minimum of 3 months on prior PD-1 or PDL-1 directed therapy were treated with FPT155 at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1a Combination: FPT155 (Dose H) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose H administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose I) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose I administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose J) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose J administered IV Q3W in combination with 200 mg Pembrolizumab.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1b Monotherapy: Vss of FPT155
|
3492.6594 mL
Standard Deviation NA
Value not estimable as only 1 participant was in the arm.
|
5006.6203 mL
Standard Deviation 1687.10134
|
4934.4888 mL
Standard Deviation 1711.72574
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 (21-day cycles) Day 1Population: Safety population: All participants who received any portion of a least one dose of FPT155.
Data presented below includes participants with at least 1 anti-drug antibodies-positive sample relative to baseline after initiation of the treatment.
Outcome measures
| Measure |
Phase 1a Monotherapy: FPT155 Dose A
n=1 Participants
Participants with advanced solid tumours received FPT155 intravenously (IV) once every 3 weeks (Q3W) in escalating doses (A-L) until the recommended dose (RD) was identified.
|
Phase 1a Monotherapy: FPT155 Dose B
n=5 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose C
n=3 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose D
n=1 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose E
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose F
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose G
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose H
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose I
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose J
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose K
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose L
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1b Monotherapy: 1bM1 FPT155 Dose K
Participants with advanced renal cell carcinoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM2 FPT155 Dose K
Participants with advanced melanoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM3 FPT155 Dose K
Participants with previously treated unresectable or metastatic non-small cell lung cancer and an absence of suitable standard treatment options were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM4 FPT155 Dose K
Participants with previously treated solid tumors with a response to prior PD-1 or PDL-1 directed treatment as defined by an objective response (partial or complete response) as determined by the Investigator per RECIST v1.1,or a minimum of 3 months on prior PD-1 or PDL-1 directed therapy were treated with FPT155 at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1a Combination: FPT155 (Dose H) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose H administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose I) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose I administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose J) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose J administered IV Q3W in combination with 200 mg Pembrolizumab.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1b Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response
Anti-FPT155 Positive
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1b Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response
Anti-FPT155 Negative
|
0 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1b Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response
Not Evaluable
|
1 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 30 monthsPopulation: Efficacy Population: All participants who received any portion of at least one dose of FPT155.
ORR was defined as the total number of participants with confirmed responses of either CR (CR: The disappearance of all target lesions, any pathological lymph nodes \[whether target or non-target\] must have a reduction in short axis to \<10 mm) or PR (PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters), as determined by the investigator per RECIST v1.1.
Outcome measures
| Measure |
Phase 1a Monotherapy: FPT155 Dose A
n=3 Participants
Participants with advanced solid tumours received FPT155 intravenously (IV) once every 3 weeks (Q3W) in escalating doses (A-L) until the recommended dose (RD) was identified.
|
Phase 1a Monotherapy: FPT155 Dose B
n=3 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose C
n=3 Participants
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose D
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose E
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose F
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose G
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose H
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose I
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose J
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose K
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose L
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1b Monotherapy: 1bM1 FPT155 Dose K
Participants with advanced renal cell carcinoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM2 FPT155 Dose K
Participants with advanced melanoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM3 FPT155 Dose K
Participants with previously treated unresectable or metastatic non-small cell lung cancer and an absence of suitable standard treatment options were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM4 FPT155 Dose K
Participants with previously treated solid tumors with a response to prior PD-1 or PDL-1 directed treatment as defined by an objective response (partial or complete response) as determined by the Investigator per RECIST v1.1,or a minimum of 3 months on prior PD-1 or PDL-1 directed therapy were treated with FPT155 at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1a Combination: FPT155 (Dose H) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose H administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose I) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose I administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose J) + Pembrolizumab 200 mg
Participants with non-small cell lung cancer were treated with FTB155 Dose J administered IV Q3W in combination with 200 mg Pembrolizumab.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1a Combination: ORR Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Phase 1a Monotherapy: FPT155 Dose A
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Phase 1a Monotherapy: FPT155 Dose B
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Phase 1a Monotherapy: FPT155 Dose C
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
Phase 1a Monotherapy: FPT155 Dose D
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Phase 1a Monotherapy: FPT155 Dose E
Serious events: 1 serious events
Other events: 3 other events
Deaths: 2 deaths
Phase 1a Monotherapy: FPT155 Dose F
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Phase 1a Monotherapy: FPT155 Dose G
Serious events: 3 serious events
Other events: 3 other events
Deaths: 1 deaths
Phase 1a Monotherapy: FPT155 Dose H
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 1a Monotherapy: FPT155 Dose I
Serious events: 2 serious events
Other events: 6 other events
Deaths: 3 deaths
Phase 1a Monotherapy: FPT155 Dose J
Serious events: 3 serious events
Other events: 10 other events
Deaths: 2 deaths
Phase 1a Monotherapy: FPT155 Dose K
Serious events: 10 serious events
Other events: 18 other events
Deaths: 4 deaths
Phase 1a Monotherapy: FPT155 Dose L
Serious events: 2 serious events
Other events: 5 other events
Deaths: 1 deaths
Phase 1b Monotherapy: 1bM1 FPT155 Dose K
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Phase 1b Monotherapy: 1bM2 FPT155 Dose K
Serious events: 0 serious events
Other events: 5 other events
Deaths: 2 deaths
Phase 1b Monotherapy: 1bM3 FPT155 Dose K
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Phase 1b Monotherapy: 1bM4 FPT155 Dose K
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Phase 1a Combination: FPT155 (Dose H) + Pembrolizumab 200 mg
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Phase 1a Combination: FPT155 (Dose I) + Pembrolizumab 200 mg
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 1a Combination: FPT155 (Dose J) + Pembrolizumab 200 mg
Serious events: 2 serious events
Other events: 2 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Phase 1a Monotherapy: FPT155 Dose A
n=1 participants at risk
Participants with advanced solid tumours received FPT155 IV Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose B
n=1 participants at risk
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose C
n=2 participants at risk
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose D
n=1 participants at risk
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose E
n=4 participants at risk
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose F
n=3 participants at risk
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose G
n=3 participants at risk
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose H
n=3 participants at risk
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose I
n=7 participants at risk
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose J
n=10 participants at risk
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose K
n=20 participants at risk
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose L
n=6 participants at risk
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1b Monotherapy: 1bM1 FPT155 Dose K
n=1 participants at risk
Participants with advanced renal cell carcinoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM2 FPT155 Dose K
n=5 participants at risk
Participants with advanced melanoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM3 FPT155 Dose K
n=3 participants at risk
Participants with previously treated unresectable or metastatic non-small cell lung cancer and an absence of suitable standard treatment options were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM4 FPT155 Dose K
n=1 participants at risk
Participants with previously treated solid tumors with a response to prior PD-1 or PDL-1 directed treatment as defined by an objective response (partial or complete response) as determined by the Investigator per RECIST v1.1,or a minimum of 3 months on prior PD-1 or PDL-1 directed therapy were treated with FPT155 at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1a Combination: FPT155 (Dose H) + Pembrolizumab 200 mg
n=3 participants at risk
Participants with non-small cell lung cancer were treated with FTB155 Dose H administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose I) + Pembrolizumab 200 mg
n=3 participants at risk
Participants with non-small cell lung cancer were treated with FTB155 Dose I administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose J) + Pembrolizumab 200 mg
n=3 participants at risk
Participants with non-small cell lung cancer were treated with FTB155 Dose J administered IV Q3W in combination with 200 mg Pembrolizumab.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
10.0%
1/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
5.0%
1/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
14.3%
1/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
16.7%
1/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
5.0%
1/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
5.0%
1/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
100.0%
1/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
5.0%
1/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
General disorders
Chest pain
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
General disorders
Suprapubic pain
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
10.0%
1/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Hepatobiliary disorders
Biliary obstruction
|
100.0%
1/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
5.0%
1/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
5.0%
1/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
16.7%
1/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
5.0%
1/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Infections and infestations
Septic shock
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
5.0%
1/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
5.0%
1/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
14.3%
1/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
10.0%
1/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
14.3%
1/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
5.0%
1/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Nervous system disorders
Central nervous system lesion
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
50.0%
1/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
14.3%
1/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
5.0%
1/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
100.0%
1/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
16.7%
1/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
5.0%
1/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
5.0%
1/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
25.0%
1/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
25.0%
1/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
14.3%
1/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
10.0%
1/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
16.7%
1/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Vascular disorders
Giant cell arteritis
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
5.0%
1/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
Other adverse events
| Measure |
Phase 1a Monotherapy: FPT155 Dose A
n=1 participants at risk
Participants with advanced solid tumours received FPT155 IV Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose B
n=1 participants at risk
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose C
n=2 participants at risk
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose D
n=1 participants at risk
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose E
n=4 participants at risk
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose F
n=3 participants at risk
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose G
n=3 participants at risk
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose H
n=3 participants at risk
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose I
n=7 participants at risk
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose J
n=10 participants at risk
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose K
n=20 participants at risk
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1a Monotherapy: FPT155 Dose L
n=6 participants at risk
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified.
|
Phase 1b Monotherapy: 1bM1 FPT155 Dose K
n=1 participants at risk
Participants with advanced renal cell carcinoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM2 FPT155 Dose K
n=5 participants at risk
Participants with advanced melanoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM3 FPT155 Dose K
n=3 participants at risk
Participants with previously treated unresectable or metastatic non-small cell lung cancer and an absence of suitable standard treatment options were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1b Monotherapy: 1bM4 FPT155 Dose K
n=1 participants at risk
Participants with previously treated solid tumors with a response to prior PD-1 or PDL-1 directed treatment as defined by an objective response (partial or complete response) as determined by the Investigator per RECIST v1.1,or a minimum of 3 months on prior PD-1 or PDL-1 directed therapy were treated with FPT155 at the RD identified in Phase 1a monotherapy (Dose K).
|
Phase 1a Combination: FPT155 (Dose H) + Pembrolizumab 200 mg
n=3 participants at risk
Participants with non-small cell lung cancer were treated with FTB155 Dose H administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose I) + Pembrolizumab 200 mg
n=3 participants at risk
Participants with non-small cell lung cancer were treated with FTB155 Dose I administered IV Q3W in combination with 200 mg Pembrolizumab.
|
Phase 1a Combination: FPT155 (Dose J) + Pembrolizumab 200 mg
n=3 participants at risk
Participants with non-small cell lung cancer were treated with FTB155 Dose J administered IV Q3W in combination with 200 mg Pembrolizumab.
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Blood and lymphatic system disorders
Anaemia
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0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
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33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
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33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
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14.3%
1/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
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10.0%
1/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
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15.0%
3/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
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16.7%
1/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
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20.0%
1/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
100.0%
1/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
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Blood and lymphatic system disorders
Lymphopenia
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0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
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0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
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25.0%
1/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
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33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
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14.3%
1/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
10.0%
1/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
14.3%
1/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
5.0%
1/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
10.0%
2/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
50.0%
1/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
5.0%
1/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Eye disorders
Vision blurred
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
50.0%
1/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
50.0%
1/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
10.0%
1/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
100.0%
1/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
10.0%
2/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
50.0%
3/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
20.0%
4/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
16.7%
1/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
25.0%
1/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
14.3%
1/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
20.0%
2/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
15.0%
3/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
2/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
100.0%
1/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
66.7%
2/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
50.0%
1/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
14.3%
1/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
20.0%
2/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
16.7%
1/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
20.0%
1/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
10.0%
1/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
50.0%
1/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
14.3%
1/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
10.0%
1/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
16.7%
1/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
14.3%
1/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
25.0%
1/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
28.6%
2/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
40.0%
4/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
15.0%
3/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
2/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
100.0%
1/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
5.0%
1/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
14.3%
1/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
20.0%
2/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
5.0%
1/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
2/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
100.0%
1/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
General disorders
Catheter site pain
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
General disorders
Chest pain
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
5.0%
1/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
General disorders
Chills
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
20.0%
4/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
100.0%
1/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
20.0%
1/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
General disorders
Discomfort
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
10.0%
1/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
General disorders
Fatigue
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
50.0%
1/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
100.0%
1/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
25.0%
1/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
66.7%
2/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
14.3%
1/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
10.0%
1/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
10.0%
2/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
50.0%
3/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
100.0%
1/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
General disorders
Feeling cold
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
16.7%
1/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
General disorders
Infusion site reaction
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
10.0%
2/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
16.7%
1/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
General disorders
Oedema peripheral
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
50.0%
1/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
10.0%
1/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
100.0%
1/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
General disorders
Pyrexia
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
15.0%
3/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
16.7%
1/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
20.0%
1/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
66.7%
2/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
5.0%
1/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
5.0%
1/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
5.0%
1/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
10.0%
1/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Infections and infestations
Infection
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
10.0%
1/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
25.0%
1/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
10.0%
1/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
5.0%
1/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
10.0%
1/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
100.0%
1/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
100.0%
1/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
25.0%
1/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
14.3%
1/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
5.0%
1/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
25.0%
1/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
14.3%
1/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
10.0%
2/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
50.0%
3/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
25.0%
1/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
10.0%
1/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
40.0%
2/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
10.0%
1/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
10.0%
2/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
20.0%
1/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
5.0%
1/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
16.7%
1/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
5.0%
1/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
10.0%
1/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
16.7%
1/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
16.7%
1/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Investigations
Platelet count decreased
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
10.0%
1/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Investigations
Transaminases increased
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
14.3%
1/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
5.0%
1/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Investigations
Weight decreased
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
10.0%
1/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
50.0%
1/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
25.0%
1/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
20.0%
2/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
15.0%
3/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
50.0%
3/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
66.7%
2/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
10.0%
1/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
5.0%
1/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
5.0%
1/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
5.0%
1/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
20.0%
1/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
25.0%
1/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
5.0%
1/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
20.0%
1/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
5.0%
1/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
20.0%
1/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
14.3%
1/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
25.0%
1/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
14.3%
1/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
10.0%
1/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
10.0%
2/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
10.0%
1/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
5.0%
1/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
5.0%
1/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
5.0%
1/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
5.0%
1/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
100.0%
1/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
10.0%
1/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
16.7%
1/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
25.0%
1/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
5.0%
1/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
50.0%
1/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
14.3%
1/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
100.0%
1/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
14.3%
1/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
20.0%
2/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
5.0%
1/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
16.7%
1/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
100.0%
1/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
14.3%
1/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
16.7%
1/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
14.3%
1/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Nervous system disorders
Lumbosacral radiculopathy
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
5.0%
1/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
5.0%
1/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Nervous system disorders
Seizure
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Nervous system disorders
Tremor
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
16.7%
1/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
100.0%
1/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
50.0%
1/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Psychiatric disorders
Depression
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
50.0%
1/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
10.0%
2/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
16.7%
1/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
5.0%
1/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
5.0%
1/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
5.0%
1/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
50.0%
1/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
100.0%
1/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
14.3%
1/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
10.0%
1/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
15.0%
3/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
100.0%
1/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
25.0%
1/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
30.0%
3/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
5.0%
1/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
66.7%
2/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
10.0%
1/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
5.0%
1/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
5.0%
1/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
10.0%
1/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
25.0%
1/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
14.3%
1/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
10.0%
1/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
25.0%
1/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
5.0%
1/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
5.0%
1/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
5.0%
1/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
16.7%
1/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
16.7%
1/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
5.0%
1/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
5.0%
1/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
20.0%
2/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
15.0%
3/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
16.7%
1/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
20.0%
1/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
66.7%
2/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
14.3%
1/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
20.0%
2/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
20.0%
4/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
66.7%
4/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
20.0%
1/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
5.0%
1/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
5.0%
1/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
10.0%
1/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
100.0%
1/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
100.0%
1/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
25.0%
1/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
20.0%
1/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
25.0%
1/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
14.3%
1/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Vascular disorders
Hypertension
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
14.3%
1/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
5.0%
1/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
25.0%
1/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
14.3%
1/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
10.0%
1/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
33.3%
1/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
14.3%
1/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
20.0%
1/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
|
Vascular disorders
Venous occlusion
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/2 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/4 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/7 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/10 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
5.0%
1/20 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/6 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/5 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/1 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
0.00%
0/3 • Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place