Trial Outcomes & Findings for FGF401 in HCC and Solid Tumors Characterized by Positive FGFR4 and KLB Expression (NCT NCT02325739)
NCT ID: NCT02325739
Last Updated: 2024-10-21
Results Overview
A dose-limiting toxicity was defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurred within the evaluation period of DLTs and met any of the criteria listed. The estimation of the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of the treatment was based upon the estimation of the probability of DLT during the evaluation period for subjects in the dose determining set (DDS). A subject with multiple occurrences of a DLT under one treatment is counted only once in the AE category for that treatment. A subject with multiple DLTs within a primary system organ class is counted only once in the total row.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
172 participants
Primary outcome timeframe
Cycle 1 (C1) (21 days) for FGF401 single agent, Cycle 1 and Cycle 2 (C2) (42 days) for FGF401 and PDR001 combination
Results posted on
2024-10-21
Participant Flow
160 subjects were enrolled \& treated with FGF401 single agent. In the Phase I part 74 subjects \& 86 subjects in the Phase II part. 12 subjects were treated in the Phase I of the combination of FGF401 and PDR001. All subjects completed the study as per protocol \& reasons for discontinuation of treatment are provided in the 'Not Completed' section.
At least 21 evaluable subjects were to be treated in Phase I for the model to have reasonable operating characteristics relating to its MTD \&/or RP2D. Each group in the Phase II dose expansion targeted a different number of subjects. Group 1 \& Group 2 planned to enroll around 40 subjects each \& Group 3 planned to enroll approximately 20 subjects.
Participant milestones
| Measure |
Phase I: 50 mg Fasted
Participants received single agent FGF401 50 mg while fasted
|
Phase I: 80 mg Fasted
Participants received single agent FGF401 80 mg while fasted
|
Phase I: 80 mg Fed
Participants received single agent FGF401 80 mg while fed
|
Phase I: 120 mg Fasted
Participants received single agent FGF401 120 mg while fasted
|
Phase I: 120 mg Fed
Participants received single agent FGF401 120 mg while fed
|
Phase I: 150 mg Fasted
Participants received single agent FGF401 150 mg while fasted
|
Phase I: FGF401 80 mg + PDR001 300 mg
Participants received FGF401 80 mg in combination with PDR001 300 mg while fasted
|
Phase I: FGF401 120 mg + PDR001 300 mg
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
|
Phase II: Group 1 - FGF401 120 mg QD
Group 1 was comprised of HCC participants from Asian contrives who took single agent FGF401 120 mg QD while fasted
|
Phase II: Group 2 - FGF401 120 mg QD
Group 2 was comprised of HCC participants from non-Asian countries who took single agent FGF401 120 mg QD while fasted
|
PhaseII: Group 3 - FGF401 120 mg QD
Group 3 was comprised of participants with other solid malignancies regardless of geography who took single agent FGF401 120 mg QD while fasted
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase I Part
STARTED
|
11
|
6
|
5
|
26
|
19
|
7
|
6
|
6
|
0
|
0
|
0
|
|
Phase I Part
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase I Part
NOT COMPLETED
|
11
|
6
|
5
|
26
|
19
|
7
|
6
|
6
|
0
|
0
|
0
|
|
Phase II Part
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
30
|
36
|
20
|
|
Phase II Part
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase II Part
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
30
|
36
|
20
|
Reasons for withdrawal
| Measure |
Phase I: 50 mg Fasted
Participants received single agent FGF401 50 mg while fasted
|
Phase I: 80 mg Fasted
Participants received single agent FGF401 80 mg while fasted
|
Phase I: 80 mg Fed
Participants received single agent FGF401 80 mg while fed
|
Phase I: 120 mg Fasted
Participants received single agent FGF401 120 mg while fasted
|
Phase I: 120 mg Fed
Participants received single agent FGF401 120 mg while fed
|
Phase I: 150 mg Fasted
Participants received single agent FGF401 150 mg while fasted
|
Phase I: FGF401 80 mg + PDR001 300 mg
Participants received FGF401 80 mg in combination with PDR001 300 mg while fasted
|
Phase I: FGF401 120 mg + PDR001 300 mg
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
|
Phase II: Group 1 - FGF401 120 mg QD
Group 1 was comprised of HCC participants from Asian contrives who took single agent FGF401 120 mg QD while fasted
|
Phase II: Group 2 - FGF401 120 mg QD
Group 2 was comprised of HCC participants from non-Asian countries who took single agent FGF401 120 mg QD while fasted
|
PhaseII: Group 3 - FGF401 120 mg QD
Group 3 was comprised of participants with other solid malignancies regardless of geography who took single agent FGF401 120 mg QD while fasted
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase I Part
Adverse Event
|
1
|
0
|
1
|
2
|
3
|
1
|
0
|
2
|
0
|
0
|
0
|
|
Phase I Part
Progressive disease
|
9
|
6
|
3
|
23
|
14
|
6
|
6
|
3
|
0
|
0
|
0
|
|
Phase I Part
Subject/guardian decision
|
1
|
0
|
1
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Phase I Part
Death
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase II Part
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
5
|
1
|
|
Phase II Part
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Phase II Part
Progressive disease
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
22
|
29
|
18
|
|
Phase II Part
Subject/guardian decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
1
|
1
|
Baseline Characteristics
FGF401 in HCC and Solid Tumors Characterized by Positive FGFR4 and KLB Expression
Baseline characteristics by cohort
| Measure |
Phase I: 50 mg Fasted
n=11 Participants
Participants received single agent FGF401 50 mg while fasted
|
Phase I: 80 mg Fasted
n=6 Participants
Participants received single agent FGF401 80 mg while fasted
|
Phase I: 80 mg Fed
n=5 Participants
Participants received single agent FGF401 80 mg while fed
|
Phase I: 120 mg Fasted
n=26 Participants
Participants received single agent FGF401 120 mg while fasted
|
Phase I: 120 mg Fed
n=19 Participants
Participants received single agent FGF401 120 mg while fed
|
Phase I: 150 mg Fasted
n=7 Participants
Participants received single agent FGF401 150 mg while fasted
|
Phase I: FGF401 80 mg + PDR001 300 mg
n=6 Participants
Participants received FGF401 80 mg in combination with PDR001 300 mg while fasted
|
Phase I: FGF401 120 mg + PDR001 300 mg
n=6 Participants
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
|
Phase II: Group 1 - FGF401 120 mg QD
n=30 Participants
Group 1 was comprised of HCC participants from Asian contrives who took single agent FGF401 120 mg QD while fasted
|
Phase II: Group 2 - FGF401 120 mg QD
n=36 Participants
Group 2 was comprised of HCC participants from non-Asian countries who took single agent FGF401 120 mg QD while fasted
|
PhaseII: Group 3 - FGF401 120 mg QD
n=20 Participants
Group 3 was comprised of participants with other solid malignancies regardless of geography who took single agent FGF401 120 mg QD while fasted
|
Total
n=172 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
18 y - <65 y
|
6 participants
n=39 Participants
|
4 participants
n=41 Participants
|
3 participants
n=35 Participants
|
14 participants
n=31 Participants
|
12 participants
n=146 Participants
|
4 participants
n=19 Participants
|
3 participants
n=147 Participants
|
3 participants
n=193 Participants
|
22 participants
|
15 participants
|
10 participants
n=19 Participants
|
96 participants
n=4 Participants
|
|
Age, Customized
65 y - <85 y
|
5 participants
n=39 Participants
|
2 participants
n=41 Participants
|
2 participants
n=35 Participants
|
12 participants
n=31 Participants
|
6 participants
n=146 Participants
|
3 participants
n=19 Participants
|
3 participants
n=147 Participants
|
3 participants
n=193 Participants
|
8 participants
|
21 participants
|
10 participants
n=19 Participants
|
75 participants
n=4 Participants
|
|
Age, Customized
>=85 y
|
0 participants
n=39 Participants
|
0 participants
n=41 Participants
|
0 participants
n=35 Participants
|
0 participants
n=31 Participants
|
1 participants
n=146 Participants
|
0 participants
n=19 Participants
|
0 participants
n=147 Participants
|
0 participants
n=193 Participants
|
0 participants
|
0 participants
|
0 participants
n=19 Participants
|
1 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
3 Participants
n=31 Participants
|
6 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=147 Participants
|
4 Participants
n=193 Participants
|
8 Participants
|
7 Participants
|
12 Participants
n=19 Participants
|
47 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
23 Participants
n=31 Participants
|
13 Participants
n=146 Participants
|
7 Participants
n=19 Participants
|
5 Participants
n=147 Participants
|
2 Participants
n=193 Participants
|
22 Participants
|
29 Participants
|
8 Participants
n=19 Participants
|
125 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
9 participants
n=39 Participants
|
2 participants
n=41 Participants
|
2 participants
n=35 Participants
|
14 participants
n=31 Participants
|
10 participants
n=146 Participants
|
4 participants
n=19 Participants
|
3 participants
n=147 Participants
|
5 participants
n=193 Participants
|
30 participants
|
0 participants
|
2 participants
n=19 Participants
|
81 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 participants
n=39 Participants
|
0 participants
n=41 Participants
|
0 participants
n=35 Participants
|
0 participants
n=31 Participants
|
1 participants
n=146 Participants
|
1 participants
n=19 Participants
|
0 participants
n=147 Participants
|
0 participants
n=193 Participants
|
0 participants
|
0 participants
|
0 participants
n=19 Participants
|
2 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
2 participants
n=39 Participants
|
4 participants
n=41 Participants
|
3 participants
n=35 Participants
|
12 participants
n=31 Participants
|
8 participants
n=146 Participants
|
1 participants
n=19 Participants
|
3 participants
n=147 Participants
|
1 participants
n=193 Participants
|
0 participants
|
21 participants
|
11 participants
n=19 Participants
|
66 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not applicable
|
0 participants
n=39 Participants
|
0 participants
n=41 Participants
|
0 participants
n=35 Participants
|
0 participants
n=31 Participants
|
0 participants
n=146 Participants
|
0 participants
n=19 Participants
|
0 participants
n=147 Participants
|
0 participants
n=193 Participants
|
0 participants
|
1 participants
|
0 participants
n=19 Participants
|
1 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=39 Participants
|
0 participants
n=41 Participants
|
0 participants
n=35 Participants
|
0 participants
n=31 Participants
|
0 participants
n=146 Participants
|
0 participants
n=19 Participants
|
0 participants
n=147 Participants
|
0 participants
n=193 Participants
|
0 participants
|
1 participants
|
0 participants
n=19 Participants
|
1 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Pacific Islander
|
0 participants
n=39 Participants
|
0 participants
n=41 Participants
|
0 participants
n=35 Participants
|
0 participants
n=31 Participants
|
0 participants
n=146 Participants
|
0 participants
n=19 Participants
|
0 participants
n=147 Participants
|
0 participants
n=193 Participants
|
0 participants
|
1 participants
|
0 participants
n=19 Participants
|
1 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 participants
n=39 Participants
|
0 participants
n=41 Participants
|
0 participants
n=35 Participants
|
0 participants
n=31 Participants
|
0 participants
n=146 Participants
|
1 participants
n=19 Participants
|
0 participants
n=147 Participants
|
0 participants
n=193 Participants
|
0 participants
|
12 participants
|
7 participants
n=19 Participants
|
20 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (C1) (21 days) for FGF401 single agent, Cycle 1 and Cycle 2 (C2) (42 days) for FGF401 and PDR001 combinationPopulation: Dose Determining Set: All subjects from safety set (Phase I) who either met the minimum exposure criterion and had sufficient safety evaluations or had experienced a DLT during the DLT evaluation period.
A dose-limiting toxicity was defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurred within the evaluation period of DLTs and met any of the criteria listed. The estimation of the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of the treatment was based upon the estimation of the probability of DLT during the evaluation period for subjects in the dose determining set (DDS). A subject with multiple occurrences of a DLT under one treatment is counted only once in the AE category for that treatment. A subject with multiple DLTs within a primary system organ class is counted only once in the total row.
Outcome measures
| Measure |
PhaseII: Group 3 - FGF401 120 mg QD
Group 3 was comprised of participants with other solid malignancies regardless of geography who took single agent FGF401 120 mg QD while fasted
|
Phase I: 50 mg Fasted
n=10 Participants
Participants received single agent FGF401 50 mg while fasted
|
Phase I: 80 mg Fasted
n=6 Participants
Participants received single agent FGF401 80 mg while fasted
|
Phase I: 80 mg Fed
n=5 Participants
Participants received single agent FGF401 80 mg while fed
|
Phase I: 120 mg Fasted
n=23 Participants
Participants received single agent FGF401 120 mg while fasted
|
Phase I: 120 mg Fed
n=18 Participants
Participants received single agent FGF401 120 mg while fed
|
Phase I: 150 mg Fasted
n=7 Participants
Participants received single agent FGF401 150 mg while fasted
|
Phase I: FGF401 80 mg + PDR001 300 mg
n=6 Participants
Participants received FGF401 80 mg in combination with PDR001 300 mg while fasted
|
Phase I: FGF401 120 mg + PDR001 300 mg
n=6 Participants
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
|
Phase II: Group 1 - FGF401 120 mg QD
Group 1 was comprised of HCC participants from Asian contrives who took single agent FGF401 120 mg QD while fasted
|
Phase II: Group 2 - FGF401 120 mg QD
Group 2 was comprised of HCC participants from non-Asian countries who took single agent FGF401 120 mg QD while fasted
|
Phase I: FGF401 120 mg + PDR001 300 mg
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
|
All Patients of Combination Dose
These were all the participants in the Phase I part who received combination dose of FGF401 and PDR001
|
All Patients
Overall participants in the in Phase I \& Phase II of study
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose-limiting Toxicity (DLT): Phase I Only
Any Primary system organ class (SOC)
|
—
|
10.0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
4.3 Percentage of participants
|
5.6 Percentage of participants
|
42.9 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Dose-limiting Toxicity (DLT): Phase I Only
Invest.: Aspartate Aminotrans. increased
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
4.3 Percentage of participants
|
0 Percentage of participants
|
42.9 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Dose-limiting Toxicity (DLT): Phase I Only
Invest.: Alanine aminotrans. increased
|
—
|
10.0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
14.3 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Dose-limiting Toxicity (DLT): Phase I Only
Invest.: Blood bilirubin increased
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
5.6 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: approx. 4.5 yearsPopulation: Full Analysis Set (FAS): Comprised all subjects who received at least one dose of study medication. Subjects enrolled in the Phase II part were analyzed by group.
TTP is defined as the date of start treatment to the date of event defined as the first documented progression or death due to underlying cancer. Method used was Kaplan-Meier analysis. Group 1: HCC subjects form Asian countries; Group 2: HCC subjects form non-Asian countries
Outcome measures
| Measure |
PhaseII: Group 3 - FGF401 120 mg QD
Group 3 was comprised of participants with other solid malignancies regardless of geography who took single agent FGF401 120 mg QD while fasted
|
Phase I: 50 mg Fasted
n=30 Participants
Participants received single agent FGF401 50 mg while fasted
|
Phase I: 80 mg Fasted
n=36 Participants
Participants received single agent FGF401 80 mg while fasted
|
Phase I: 80 mg Fed
Participants received single agent FGF401 80 mg while fed
|
Phase I: 120 mg Fasted
Participants received single agent FGF401 120 mg while fasted
|
Phase I: 120 mg Fed
Participants received single agent FGF401 120 mg while fed
|
Phase I: 150 mg Fasted
Participants received single agent FGF401 150 mg while fasted
|
Phase I: FGF401 80 mg + PDR001 300 mg
Participants received FGF401 80 mg in combination with PDR001 300 mg while fasted
|
Phase I: FGF401 120 mg + PDR001 300 mg
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
|
Phase II: Group 1 - FGF401 120 mg QD
Group 1 was comprised of HCC participants from Asian contrives who took single agent FGF401 120 mg QD while fasted
|
Phase II: Group 2 - FGF401 120 mg QD
Group 2 was comprised of HCC participants from non-Asian countries who took single agent FGF401 120 mg QD while fasted
|
Phase I: FGF401 120 mg + PDR001 300 mg
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
|
All Patients of Combination Dose
These were all the participants in the Phase I part who received combination dose of FGF401 and PDR001
|
All Patients
Overall participants in the in Phase I \& Phase II of study
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Progression (TTP): Group 1 & Group 2 (Phase II Only)
|
—
|
2.6 months
Interval 1.3 to
NA: it was pre-specified in the Statistical Plan to generate only one-sided 90% Confidence Interval for this Outcome Measure. Therefore, the upper limit is unavailable
|
3.9 months
Interval 2.9 to
NA: it was pre-specified in the Statistical Plan to generate only one-sided 90% Confidence Intervals for this Outcome Measure. Therefore, the upper limit is unavailable
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: approx. 4.5 yearsPopulation: FAS: The full analysis set (FAS) comprised all subjects who received at least one dose of study medication. Subjects enrolled in the Phase II part were analyzed by group.
ORR is defined as the percentage of patients with a best overall response of CR or PR (RECIST v1.1). FGF401 single agent-Phase II part - Group 3 (non-HCC, other solid tumors).
Outcome measures
| Measure |
PhaseII: Group 3 - FGF401 120 mg QD
Group 3 was comprised of participants with other solid malignancies regardless of geography who took single agent FGF401 120 mg QD while fasted
|
Phase I: 50 mg Fasted
n=20 Participants
Participants received single agent FGF401 50 mg while fasted
|
Phase I: 80 mg Fasted
Participants received single agent FGF401 80 mg while fasted
|
Phase I: 80 mg Fed
Participants received single agent FGF401 80 mg while fed
|
Phase I: 120 mg Fasted
Participants received single agent FGF401 120 mg while fasted
|
Phase I: 120 mg Fed
Participants received single agent FGF401 120 mg while fed
|
Phase I: 150 mg Fasted
Participants received single agent FGF401 150 mg while fasted
|
Phase I: FGF401 80 mg + PDR001 300 mg
Participants received FGF401 80 mg in combination with PDR001 300 mg while fasted
|
Phase I: FGF401 120 mg + PDR001 300 mg
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
|
Phase II: Group 1 - FGF401 120 mg QD
Group 1 was comprised of HCC participants from Asian contrives who took single agent FGF401 120 mg QD while fasted
|
Phase II: Group 2 - FGF401 120 mg QD
Group 2 was comprised of HCC participants from non-Asian countries who took single agent FGF401 120 mg QD while fasted
|
Phase I: FGF401 120 mg + PDR001 300 mg
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
|
All Patients of Combination Dose
These were all the participants in the Phase I part who received combination dose of FGF401 and PDR001
|
All Patients
Overall participants in the in Phase I \& Phase II of study
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Response Rate (ORR) Based on Local Assessment: Group 3 (Phase II Only)
|
—
|
0 Percentage of participants
Interval 0.0 to 16.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: approx. 4.5 yearsPopulation: FAS: The full analysis set (FAS) comprised all subjects who received at least one dose of study medication. Subjects enrolled in the Phase I part were analyzed according to the treatment they had been assigned to. Subjects enrolled in the Phase II part were analyzed by group.
BOR is the best response recorded from the start of the treatment until disease progression/recurrence. BOR is determined according to: complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD) and unknown.
Outcome measures
| Measure |
PhaseII: Group 3 - FGF401 120 mg QD
n=20 Participants
Group 3 was comprised of participants with other solid malignancies regardless of geography who took single agent FGF401 120 mg QD while fasted
|
Phase I: 50 mg Fasted
n=11 Participants
Participants received single agent FGF401 50 mg while fasted
|
Phase I: 80 mg Fasted
n=6 Participants
Participants received single agent FGF401 80 mg while fasted
|
Phase I: 80 mg Fed
n=5 Participants
Participants received single agent FGF401 80 mg while fed
|
Phase I: 120 mg Fasted
n=26 Participants
Participants received single agent FGF401 120 mg while fasted
|
Phase I: 120 mg Fed
n=19 Participants
Participants received single agent FGF401 120 mg while fed
|
Phase I: 150 mg Fasted
n=7 Participants
Participants received single agent FGF401 150 mg while fasted
|
Phase I: FGF401 80 mg + PDR001 300 mg
n=6 Participants
Participants received FGF401 80 mg in combination with PDR001 300 mg while fasted
|
Phase I: FGF401 120 mg + PDR001 300 mg
n=6 Participants
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
|
Phase II: Group 1 - FGF401 120 mg QD
n=30 Participants
Group 1 was comprised of HCC participants from Asian contrives who took single agent FGF401 120 mg QD while fasted
|
Phase II: Group 2 - FGF401 120 mg QD
n=36 Participants
Group 2 was comprised of HCC participants from non-Asian countries who took single agent FGF401 120 mg QD while fasted
|
Phase I: FGF401 120 mg + PDR001 300 mg
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
|
All Patients of Combination Dose
These were all the participants in the Phase I part who received combination dose of FGF401 and PDR001
|
All Patients
Overall participants in the in Phase I \& Phase II of study
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Best Overall Response (BOR) by Investigator Assessment: Phase I and Phase II
Complete Response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Best Overall Response (BOR) by Investigator Assessment: Phase I and Phase II
Partial Response
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Best Overall Response (BOR) by Investigator Assessment: Phase I and Phase II
Stable Disease
|
6 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
12 Participants
|
9 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
11 Participants
|
20 Participants
|
—
|
—
|
—
|
|
Best Overall Response (BOR) by Investigator Assessment: Phase I and Phase II
Progressive Disease
|
12 Participants
|
7 Participants
|
4 Participants
|
1 Participants
|
11 Participants
|
8 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
16 Participants
|
6 Participants
|
—
|
—
|
—
|
|
Best Overall Response (BOR) by Investigator Assessment: Phase I and Phase II
Unknown
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
8 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: approx. 4.5 yearsPopulation: FAS: The FAS comprised all subjects who received at least one dose of study medication. Subjects enrolled in the Phase I part were analyzed according to the treatment they had been assigned to. Subjects enrolled in the Phase II part were analyzed by group.
ORR is defined as the proportion of patients with a best overall response of CR or PR (RECIST v1.1). Phase I part and FGF401 single agent Phase II Group 1 (HCC, Asians) and Group 2 (HCC, non-Asians)
Outcome measures
| Measure |
PhaseII: Group 3 - FGF401 120 mg QD
Group 3 was comprised of participants with other solid malignancies regardless of geography who took single agent FGF401 120 mg QD while fasted
|
Phase I: 50 mg Fasted
n=11 Participants
Participants received single agent FGF401 50 mg while fasted
|
Phase I: 80 mg Fasted
n=6 Participants
Participants received single agent FGF401 80 mg while fasted
|
Phase I: 80 mg Fed
n=5 Participants
Participants received single agent FGF401 80 mg while fed
|
Phase I: 120 mg Fasted
n=26 Participants
Participants received single agent FGF401 120 mg while fasted
|
Phase I: 120 mg Fed
n=19 Participants
Participants received single agent FGF401 120 mg while fed
|
Phase I: 150 mg Fasted
n=7 Participants
Participants received single agent FGF401 150 mg while fasted
|
Phase I: FGF401 80 mg + PDR001 300 mg
n=6 Participants
Participants received FGF401 80 mg in combination with PDR001 300 mg while fasted
|
Phase I: FGF401 120 mg + PDR001 300 mg
n=6 Participants
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
|
Phase II: Group 1 - FGF401 120 mg QD
n=30 Participants
Group 1 was comprised of HCC participants from Asian contrives who took single agent FGF401 120 mg QD while fasted
|
Phase II: Group 2 - FGF401 120 mg QD
n=36 Participants
Group 2 was comprised of HCC participants from non-Asian countries who took single agent FGF401 120 mg QD while fasted
|
Phase I: FGF401 120 mg + PDR001 300 mg
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
|
All Patients of Combination Dose
These were all the participants in the Phase I part who received combination dose of FGF401 and PDR001
|
All Patients
Overall participants in the in Phase I \& Phase II of study
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Response Rate (ORR) by Investigator Assessment Phase I and FGF401 Single Agent Phase II Groups 1 & 2
|
—
|
0 Percentage of participants
Interval 0.0 to 28.5
|
16.7 Percentage of participants
Interval 0.4 to 64.1
|
20.0 Percentage of participants
Interval 0.5 to 71.6
|
3.8 Percentage of participants
Interval 0.1 to 19.6
|
0 Percentage of participants
Interval 0.0 to 17.6
|
14.3 Percentage of participants
Interval 0.4 to 57.9
|
16.7 Percentage of participants
Interval 0.4 to 64.1
|
16.7 Percentage of participants
Interval 0.4 to 64.1
|
6.7 Percentage of participants
Interval 0.8 to 22.1
|
5.6 Percentage of participants
Interval 0.7 to 18.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: approx. 4.5 yearsPopulation: FAS: The FAS comprised all subjects who received at least one dose of study medication. Subjects enrolled in the Phase I part were analyzed according to the treatment they had been assigned to. Subjects enrolled in the Phase II part were analyzed by group.
DCR is the percentage of participants with a best overall response of CR or PR or SD per local assessment according to RECIST v1.1. Phase I part and FGF401 single agent Phase II Group 1 (HCC, Asians) and Group 2 (HCC, non-Asians) and Group 3 (non-HCC, other solid tumors).
Outcome measures
| Measure |
PhaseII: Group 3 - FGF401 120 mg QD
n=20 Participants
Group 3 was comprised of participants with other solid malignancies regardless of geography who took single agent FGF401 120 mg QD while fasted
|
Phase I: 50 mg Fasted
n=11 Participants
Participants received single agent FGF401 50 mg while fasted
|
Phase I: 80 mg Fasted
n=6 Participants
Participants received single agent FGF401 80 mg while fasted
|
Phase I: 80 mg Fed
n=5 Participants
Participants received single agent FGF401 80 mg while fed
|
Phase I: 120 mg Fasted
n=26 Participants
Participants received single agent FGF401 120 mg while fasted
|
Phase I: 120 mg Fed
n=19 Participants
Participants received single agent FGF401 120 mg while fed
|
Phase I: 150 mg Fasted
n=7 Participants
Participants received single agent FGF401 150 mg while fasted
|
Phase I: FGF401 80 mg + PDR001 300 mg
n=6 Participants
Participants received FGF401 80 mg in combination with PDR001 300 mg while fasted
|
Phase I: FGF401 120 mg + PDR001 300 mg
n=6 Participants
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
|
Phase II: Group 1 - FGF401 120 mg QD
n=30 Participants
Group 1 was comprised of HCC participants from Asian contrives who took single agent FGF401 120 mg QD while fasted
|
Phase II: Group 2 - FGF401 120 mg QD
n=36 Participants
Group 2 was comprised of HCC participants from non-Asian countries who took single agent FGF401 120 mg QD while fasted
|
Phase I: FGF401 120 mg + PDR001 300 mg
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
|
All Patients of Combination Dose
These were all the participants in the Phase I part who received combination dose of FGF401 and PDR001
|
All Patients
Overall participants in the in Phase I \& Phase II of study
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Disease Control Rate (DCR) by Local Investigator Assessment Phase I and FGF401 Single Agent Phase II Groups 1, 2 & 3
|
30.0 percentage of participants
Interval 11.9 to 54.3
|
18.2 percentage of participants
Interval 2.3 to 51.8
|
33.3 percentage of participants
Interval 4.3 to 77.7
|
60.0 percentage of participants
Interval 14.7 to 94.7
|
50.0 percentage of participants
Interval 29.9 to 70.1
|
47.4 percentage of participants
Interval 24.4 to 71.1
|
71.4 percentage of participants
Interval 29.0 to 96.3
|
50.0 percentage of participants
Interval 11.8 to 88.2
|
50.0 percentage of participants
Interval 11.8 to 88.2
|
43.3 percentage of participants
Interval 25.5 to 62.6
|
61.1 percentage of participants
Interval 43.5 to 76.9
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: approx. 4.5 yearsPopulation: The full analysis set (FAS) comprised all subjects who received at least one dose of study medication. Subjects enrolled in the Phase I part were analyzed according to the treatment they had been assigned to.
TTP is defined as the date of start treatment to the date of event defined as the first documented progression or death due to underlying cancer. Method used was Kaplan-Meier analysis.
Outcome measures
| Measure |
PhaseII: Group 3 - FGF401 120 mg QD
Group 3 was comprised of participants with other solid malignancies regardless of geography who took single agent FGF401 120 mg QD while fasted
|
Phase I: 50 mg Fasted
n=26 Participants
Participants received single agent FGF401 50 mg while fasted
|
Phase I: 80 mg Fasted
n=19 Participants
Participants received single agent FGF401 80 mg while fasted
|
Phase I: 80 mg Fed
n=6 Participants
Participants received single agent FGF401 80 mg while fed
|
Phase I: 120 mg Fasted
Participants received single agent FGF401 120 mg while fasted
|
Phase I: 120 mg Fed
Participants received single agent FGF401 120 mg while fed
|
Phase I: 150 mg Fasted
Participants received single agent FGF401 150 mg while fasted
|
Phase I: FGF401 80 mg + PDR001 300 mg
Participants received FGF401 80 mg in combination with PDR001 300 mg while fasted
|
Phase I: FGF401 120 mg + PDR001 300 mg
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
|
Phase II: Group 1 - FGF401 120 mg QD
Group 1 was comprised of HCC participants from Asian contrives who took single agent FGF401 120 mg QD while fasted
|
Phase II: Group 2 - FGF401 120 mg QD
Group 2 was comprised of HCC participants from non-Asian countries who took single agent FGF401 120 mg QD while fasted
|
Phase I: FGF401 120 mg + PDR001 300 mg
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
|
All Patients of Combination Dose
These were all the participants in the Phase I part who received combination dose of FGF401 and PDR001
|
All Patients
Overall participants in the in Phase I \& Phase II of study
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Progression (TTP) in Participants Dosed With Single Agent FGF401 120 mg (Fasted & Fed) & With Combination FGF401 120 mg + PDR001 300 mg Q3W (Phase I)
|
—
|
4.1 months
Interval 1.6 to
NA: it was pre-specified in the Statistical Plan to generate only one-sided 90% Confidence Interval for this Outcome Measure. Therefore, the upper limit is unavailable
|
2.0 months
Interval 1.4 to
NA: it was pre-specified in the Statistical Plan to generate only one-sided 90% Confidence Interval for this Outcome Measure. Therefore, the upper limit is unavailable
|
5.3 months
Interval 3.0 to
NA: it was pre-specified in the Statistical Plan to generate only one-sided 90% Confidence Interval for this Outcome Measure. Therefore, the upper limit is unavailable
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: start of treatment to death, up to about 53 monthsPopulation: FAS: The full analysis set (FAS) comprised all subjects who received at least one dose of study medication. Subjects enrolled in the Phase I part were analyzed according to the treatment they had been assigned to. Subjects enrolled in the Phase II part were analyzed by group.
Overall survival (OS) is defined as the time from date of start of treatment to date of death due to any cause. If a patient was not known to have died, survival was censored at the date of last known date patient alive. Method used was Kaplan-Meier analysis.
Outcome measures
| Measure |
PhaseII: Group 3 - FGF401 120 mg QD
Group 3 was comprised of participants with other solid malignancies regardless of geography who took single agent FGF401 120 mg QD while fasted
|
Phase I: 50 mg Fasted
n=26 Participants
Participants received single agent FGF401 50 mg while fasted
|
Phase I: 80 mg Fasted
n=19 Participants
Participants received single agent FGF401 80 mg while fasted
|
Phase I: 80 mg Fed
n=6 Participants
Participants received single agent FGF401 80 mg while fed
|
Phase I: 120 mg Fasted
n=30 Participants
Participants received single agent FGF401 120 mg while fasted
|
Phase I: 120 mg Fed
n=36 Participants
Participants received single agent FGF401 120 mg while fed
|
Phase I: 150 mg Fasted
n=20 Participants
Participants received single agent FGF401 150 mg while fasted
|
Phase I: FGF401 80 mg + PDR001 300 mg
Participants received FGF401 80 mg in combination with PDR001 300 mg while fasted
|
Phase I: FGF401 120 mg + PDR001 300 mg
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
|
Phase II: Group 1 - FGF401 120 mg QD
Group 1 was comprised of HCC participants from Asian contrives who took single agent FGF401 120 mg QD while fasted
|
Phase II: Group 2 - FGF401 120 mg QD
Group 2 was comprised of HCC participants from non-Asian countries who took single agent FGF401 120 mg QD while fasted
|
Phase I: FGF401 120 mg + PDR001 300 mg
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
|
All Patients of Combination Dose
These were all the participants in the Phase I part who received combination dose of FGF401 and PDR001
|
All Patients
Overall participants in the in Phase I \& Phase II of study
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival (OS) in Participants Dosed With Single Agent FGF401 120 mg (Fasted & Fed) and in Participants Dosed With Combination FGF401 120 mg and PDR001 300 mg Q3W (Phase I & II)
|
—
|
7.0 months
Interval 5.1 to
NA: it was pre-specified in the Statistical Plan to generate only one-sided 90% Confidence Interval for this Outcome Measure. Therefore, the upper limit is unavailable
|
4.9 months
Interval 2.6 to
NA: it was pre-specified in the Statistical Plan to generate only one-sided 90% Confidence Interval for this Outcome Measure. Therefore, the upper limit is unavailable
|
NA months
NA: did not observe enough events to calculate these parameters
|
5.9 months
Interval 5.1 to
NA: it was pre-specified in the Statistical Plan to generate only one-sided 90% Confidence Interval for this Outcome Measure. Therefore, the upper limit is unavailable
|
10.9 months
Interval 7.9 to
NA: it was pre-specified in the Statistical Plan to generate only one-sided 90% Confidence Interval for this Outcome Measure. Therefore, the upper limit is unavailable
|
6.2 months
Interval 4.2 to
NA: it was pre-specified in the Statistical Plan to generate only one-sided 90% Confidence Interval for this Outcome Measure. Therefore, the upper limit is unavailable
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 4.5 yearsPopulation: Full Analysis Set (FAS): Comprised all subjects who received at least one dose of study medication. Subjects enrolled in the Phase II part were analyzed by group.
Progression-free survival (PFS) is the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, progression-free survival is censored at the date of last adequate tumor assessment. Group 3 - non-HCC, other solid tumors. Method used was Kaplan-Meier analysis.
Outcome measures
| Measure |
PhaseII: Group 3 - FGF401 120 mg QD
Group 3 was comprised of participants with other solid malignancies regardless of geography who took single agent FGF401 120 mg QD while fasted
|
Phase I: 50 mg Fasted
n=20 Participants
Participants received single agent FGF401 50 mg while fasted
|
Phase I: 80 mg Fasted
Participants received single agent FGF401 80 mg while fasted
|
Phase I: 80 mg Fed
Participants received single agent FGF401 80 mg while fed
|
Phase I: 120 mg Fasted
Participants received single agent FGF401 120 mg while fasted
|
Phase I: 120 mg Fed
Participants received single agent FGF401 120 mg while fed
|
Phase I: 150 mg Fasted
Participants received single agent FGF401 150 mg while fasted
|
Phase I: FGF401 80 mg + PDR001 300 mg
Participants received FGF401 80 mg in combination with PDR001 300 mg while fasted
|
Phase I: FGF401 120 mg + PDR001 300 mg
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
|
Phase II: Group 1 - FGF401 120 mg QD
Group 1 was comprised of HCC participants from Asian contrives who took single agent FGF401 120 mg QD while fasted
|
Phase II: Group 2 - FGF401 120 mg QD
Group 2 was comprised of HCC participants from non-Asian countries who took single agent FGF401 120 mg QD while fasted
|
Phase I: FGF401 120 mg + PDR001 300 mg
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
|
All Patients of Combination Dose
These were all the participants in the Phase I part who received combination dose of FGF401 and PDR001
|
All Patients
Overall participants in the in Phase I \& Phase II of study
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Progression-free Survival (PFS) - FGF401 Single Agent Phase II: Group 3
|
—
|
1.4 months
Interval 1.4 to 2.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 of Cycle 1 to 6, approx. 10 months after C1D1 and 150-day safety follow up (FU)Population: FAS: The full analysis set (FAS) comprised all subjects who received at least one dose of study medication. Subjects enrolled in the Phase I part were analyzed according to the treatment they had been assigned to.
Serum PDR001 concentrations as well as immunogenicity analysis were performed for all subjects receiving PDR001. Treatment-induced ADA-positive percentage was based on percentage subjects ADA-negative at baseline. Treatment-boosted ADA-positive percentage was based on subjects ADA-positive at baseline.
Outcome measures
| Measure |
PhaseII: Group 3 - FGF401 120 mg QD
Group 3 was comprised of participants with other solid malignancies regardless of geography who took single agent FGF401 120 mg QD while fasted
|
Phase I: 50 mg Fasted
n=6 Participants
Participants received single agent FGF401 50 mg while fasted
|
Phase I: 80 mg Fasted
n=6 Participants
Participants received single agent FGF401 80 mg while fasted
|
Phase I: 80 mg Fed
Participants received single agent FGF401 80 mg while fed
|
Phase I: 120 mg Fasted
Participants received single agent FGF401 120 mg while fasted
|
Phase I: 120 mg Fed
Participants received single agent FGF401 120 mg while fed
|
Phase I: 150 mg Fasted
Participants received single agent FGF401 150 mg while fasted
|
Phase I: FGF401 80 mg + PDR001 300 mg
Participants received FGF401 80 mg in combination with PDR001 300 mg while fasted
|
Phase I: FGF401 120 mg + PDR001 300 mg
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
|
Phase II: Group 1 - FGF401 120 mg QD
Group 1 was comprised of HCC participants from Asian contrives who took single agent FGF401 120 mg QD while fasted
|
Phase II: Group 2 - FGF401 120 mg QD
Group 2 was comprised of HCC participants from non-Asian countries who took single agent FGF401 120 mg QD while fasted
|
Phase I: FGF401 120 mg + PDR001 300 mg
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
|
All Patients of Combination Dose
These were all the participants in the Phase I part who received combination dose of FGF401 and PDR001
|
All Patients
Overall participants in the in Phase I \& Phase II of study
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Presence and/or Concentration of Anti-PDR001 Antibodies
ADA-negative
|
—
|
100.0 percentage of participants
|
83.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Presence and/or Concentration of Anti-PDR001 Antibodies
ADA-positive (i.e. ADA incidence)
|
—
|
0 percentage of participants
|
16.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Presence and/or Concentration of Anti-PDR001 Antibodies
Treatment-induced ADA-positive
|
—
|
0 percentage of participants
|
20.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Presence and/or Concentration of Anti-PDR001 Antibodies
Treatment-boosted ADA-positive
|
—
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: After the first dosing sample collection was at: C1D1 0hr , C1D1 1hr, C1D8 168hr, C1D15 336hr, C2D1 504hr; each cycle is 21 daysPopulation: The PAS included all subjects who provided at least one evaluable drug concentration. For those requiring non-compartment analyses, the PAS included all subjects who provided an evaluable PK profile.
Cmax is the maximum (peak) observed plasma drug concentration (mass x volume-1)
Outcome measures
| Measure |
PhaseII: Group 3 - FGF401 120 mg QD
Group 3 was comprised of participants with other solid malignancies regardless of geography who took single agent FGF401 120 mg QD while fasted
|
Phase I: 50 mg Fasted
n=6 Participants
Participants received single agent FGF401 50 mg while fasted
|
Phase I: 80 mg Fasted
n=6 Participants
Participants received single agent FGF401 80 mg while fasted
|
Phase I: 80 mg Fed
Participants received single agent FGF401 80 mg while fed
|
Phase I: 120 mg Fasted
Participants received single agent FGF401 120 mg while fasted
|
Phase I: 120 mg Fed
Participants received single agent FGF401 120 mg while fed
|
Phase I: 150 mg Fasted
Participants received single agent FGF401 150 mg while fasted
|
Phase I: FGF401 80 mg + PDR001 300 mg
Participants received FGF401 80 mg in combination with PDR001 300 mg while fasted
|
Phase I: FGF401 120 mg + PDR001 300 mg
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
|
Phase II: Group 1 - FGF401 120 mg QD
Group 1 was comprised of HCC participants from Asian contrives who took single agent FGF401 120 mg QD while fasted
|
Phase II: Group 2 - FGF401 120 mg QD
Group 2 was comprised of HCC participants from non-Asian countries who took single agent FGF401 120 mg QD while fasted
|
Phase I: FGF401 120 mg + PDR001 300 mg
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
|
All Patients of Combination Dose
These were all the participants in the Phase I part who received combination dose of FGF401 and PDR001
|
All Patients
Overall participants in the in Phase I \& Phase II of study
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax of PDR001 in Combination With FGF401: Phase I
|
—
|
74.7 μg/mL
Geometric Coefficient of Variation 43.0
|
87.7 μg/mL
Geometric Coefficient of Variation 5.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: After the first dosing sample collection was at: C1D1 0hr , C1D1 1hr, C1D8 168hr, C1D15 336hr, C2D1 504hr; each cycle is 21 daysPopulation: The PAS included all subjects who provided at least one evaluable drug concentration. For those requiring non-compartment analyses, the PAS included all subjects who provided an evaluable PK profile
AUClast: The AUC from time zero to the last measurable concentration sampling time (Tlast) (mass x time x volume-1) AUCtau (AUC0 504h): The AUC calculated to the end of a dosing interval (tau) (amount x time x volume-1)
Outcome measures
| Measure |
PhaseII: Group 3 - FGF401 120 mg QD
Group 3 was comprised of participants with other solid malignancies regardless of geography who took single agent FGF401 120 mg QD while fasted
|
Phase I: 50 mg Fasted
n=6 Participants
Participants received single agent FGF401 50 mg while fasted
|
Phase I: 80 mg Fasted
n=6 Participants
Participants received single agent FGF401 80 mg while fasted
|
Phase I: 80 mg Fed
Participants received single agent FGF401 80 mg while fed
|
Phase I: 120 mg Fasted
Participants received single agent FGF401 120 mg while fasted
|
Phase I: 120 mg Fed
Participants received single agent FGF401 120 mg while fed
|
Phase I: 150 mg Fasted
Participants received single agent FGF401 150 mg while fasted
|
Phase I: FGF401 80 mg + PDR001 300 mg
Participants received FGF401 80 mg in combination with PDR001 300 mg while fasted
|
Phase I: FGF401 120 mg + PDR001 300 mg
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
|
Phase II: Group 1 - FGF401 120 mg QD
Group 1 was comprised of HCC participants from Asian contrives who took single agent FGF401 120 mg QD while fasted
|
Phase II: Group 2 - FGF401 120 mg QD
Group 2 was comprised of HCC participants from non-Asian countries who took single agent FGF401 120 mg QD while fasted
|
Phase I: FGF401 120 mg + PDR001 300 mg
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
|
All Patients of Combination Dose
These were all the participants in the Phase I part who received combination dose of FGF401 and PDR001
|
All Patients
Overall participants in the in Phase I \& Phase II of study
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUClast and AUCtau of PDR001 in Combination of FGF401: Phase I
AUClast
|
—
|
795 day*μg/mL
Geometric Coefficient of Variation 34.5
|
978 day*μg/mL
Geometric Coefficient of Variation 15.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AUClast and AUCtau of PDR001 in Combination of FGF401: Phase I
AUC0-504h (n = 3, 6)
|
—
|
760 day*μg/mL
Geometric Coefficient of Variation 1.9
|
967 day*μg/mL
Geometric Coefficient of Variation 13.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: After the first dosing sample collection was at: C1D1 0hr , C1D1 1hr, C1D8 168hr, C1D15 336hr, C2D1 504hr; each cycle is 21 daysPopulation: The PAS incl. all subjects who provided at least one evaluable drug concentration. For those requiring non-compartment analyses, PAS incl. all subjects who provided an evaluable PK profile. Due to the sparse PK sampling designed for PDR001, PDR001 concentration data was insufficient for accurate estimation of secondary PK parameters including T1/2.
Due to the sparse PK sampling designed from PDR001, the PDR001 concentration data was insufficient for accurate estimation of secondary PK parameters including T1/2.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: C1D1 (0 hour (h), 0.5h, 1h, 2h, 3h, 4h, 6h, 12h, 24h), C1D8 (0h, 0.5h, 1h, 2h, 3h, 4h, 6h, 12h, 24h), and C2D1 (0h, 0.5h, 1h, 2h, 3h, 4h, 6h, 12h, 24h)Population: The PAS included all subjects who provided at least one evaluable drug concentration. For those requiring non-compartment analyses, the PAS included all subjects who provided an evaluable PK profile.
Cmax is the maximum (peak) observed plasma drug concentration (mass x volume-1)
Outcome measures
| Measure |
PhaseII: Group 3 - FGF401 120 mg QD
Group 3 was comprised of participants with other solid malignancies regardless of geography who took single agent FGF401 120 mg QD while fasted
|
Phase I: 50 mg Fasted
n=10 Participants
Participants received single agent FGF401 50 mg while fasted
|
Phase I: 80 mg Fasted
n=6 Participants
Participants received single agent FGF401 80 mg while fasted
|
Phase I: 80 mg Fed
n=5 Participants
Participants received single agent FGF401 80 mg while fed
|
Phase I: 120 mg Fasted
n=26 Participants
Participants received single agent FGF401 120 mg while fasted
|
Phase I: 120 mg Fed
n=19 Participants
Participants received single agent FGF401 120 mg while fed
|
Phase I: 150 mg Fasted
n=7 Participants
Participants received single agent FGF401 150 mg while fasted
|
Phase I: FGF401 80 mg + PDR001 300 mg
Participants received FGF401 80 mg in combination with PDR001 300 mg while fasted
|
Phase I: FGF401 120 mg + PDR001 300 mg
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
|
Phase II: Group 1 - FGF401 120 mg QD
Group 1 was comprised of HCC participants from Asian contrives who took single agent FGF401 120 mg QD while fasted
|
Phase II: Group 2 - FGF401 120 mg QD
Group 2 was comprised of HCC participants from non-Asian countries who took single agent FGF401 120 mg QD while fasted
|
Phase I: FGF401 120 mg + PDR001 300 mg
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
|
All Patients of Combination Dose
These were all the participants in the Phase I part who received combination dose of FGF401 and PDR001
|
All Patients
Overall participants in the in Phase I \& Phase II of study
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax of FGF401: Phase I
Cycle 2 Day 1
|
—
|
696 ng/mL
Geometric Coefficient of Variation 44.2
|
786 ng/mL
Geometric Coefficient of Variation 25.5
|
703 ng/mL
Geometric Coefficient of Variation 41.7
|
1070 ng/mL
Geometric Coefficient of Variation 32.2
|
1000 ng/mL
Geometric Coefficient of Variation 23.9
|
1350 ng/mL
Geometric Coefficient of Variation 28.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cmax of FGF401: Phase I
Cycle 1 Day 1
|
—
|
698 ng/mL
Geometric Coefficient of Variation 36.1
|
967 ng/mL
Geometric Coefficient of Variation 25.0
|
659 ng/mL
Geometric Coefficient of Variation 15.2
|
1090 ng/mL
Geometric Coefficient of Variation 37.9
|
1050 ng/mL
Geometric Coefficient of Variation 32.3
|
1400 ng/mL
Geometric Coefficient of Variation 32.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cmax of FGF401: Phase I
Cycle 1 Day 8
|
—
|
663 ng/mL
Geometric Coefficient of Variation 46.8
|
838 ng/mL
Geometric Coefficient of Variation 16.5
|
704 ng/mL
Geometric Coefficient of Variation 22.1
|
1120 ng/mL
Geometric Coefficient of Variation 36.5
|
1060 ng/mL
Geometric Coefficient of Variation 22.1
|
1070 ng/mL
Geometric Coefficient of Variation 46.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: C1D1 (0h, 0.5h, 1h, 2h, 3h, 4h, 6h, 12h, 24h)Population: The PAS included all subjects who provided at least one evaluable drug concentration. For those requiring non-compartment analyses, the PAS included all subjects who provided an evaluable PK profile.
Cmax is the maximum (peak) observed plasma drug concentration (mass x volume-1)
Outcome measures
| Measure |
PhaseII: Group 3 - FGF401 120 mg QD
Group 3 was comprised of participants with other solid malignancies regardless of geography who took single agent FGF401 120 mg QD while fasted
|
Phase I: 50 mg Fasted
n=6 Participants
Participants received single agent FGF401 50 mg while fasted
|
Phase I: 80 mg Fasted
n=6 Participants
Participants received single agent FGF401 80 mg while fasted
|
Phase I: 80 mg Fed
Participants received single agent FGF401 80 mg while fed
|
Phase I: 120 mg Fasted
Participants received single agent FGF401 120 mg while fasted
|
Phase I: 120 mg Fed
Participants received single agent FGF401 120 mg while fed
|
Phase I: 150 mg Fasted
Participants received single agent FGF401 150 mg while fasted
|
Phase I: FGF401 80 mg + PDR001 300 mg
Participants received FGF401 80 mg in combination with PDR001 300 mg while fasted
|
Phase I: FGF401 120 mg + PDR001 300 mg
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
|
Phase II: Group 1 - FGF401 120 mg QD
Group 1 was comprised of HCC participants from Asian contrives who took single agent FGF401 120 mg QD while fasted
|
Phase II: Group 2 - FGF401 120 mg QD
Group 2 was comprised of HCC participants from non-Asian countries who took single agent FGF401 120 mg QD while fasted
|
Phase I: FGF401 120 mg + PDR001 300 mg
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
|
All Patients of Combination Dose
These were all the participants in the Phase I part who received combination dose of FGF401 and PDR001
|
All Patients
Overall participants in the in Phase I \& Phase II of study
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax of FGF401 in Combination With PDR001: Phase I
|
—
|
732 ng/mL
Geometric Coefficient of Variation 26.8
|
1450 ng/mL
Geometric Coefficient of Variation 31.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: C1D1 (0h, 0.5h, 1h, 2h, 3h, 4h, 6h, 12h, 24h), C1D8 (0h, 0.5h, 1h, 2h, 3h, 4h, 6h, 12h, 24h), and C2D1 (0h, 0.5h, 1h, 2h, 3h, 4h, 6h, 12h, 24h)Population: The PAS included all subjects who provided at least one evaluable drug concentration. For those requiring non-compartment analyses, the PAS included all subjects who provided an evaluable PK profile.
AUCinf: The AUC from time zero to infinity (mass x time x volume-1) AUClast: The AUC from time zero to the last measurable concentration sampling time (Tlast) (mass x time x volume-1) AUCtau: The AUC calculated to the end of a dosing interval (tau) (amount x time x volume-1)
Outcome measures
| Measure |
PhaseII: Group 3 - FGF401 120 mg QD
Group 3 was comprised of participants with other solid malignancies regardless of geography who took single agent FGF401 120 mg QD while fasted
|
Phase I: 50 mg Fasted
n=10 Participants
Participants received single agent FGF401 50 mg while fasted
|
Phase I: 80 mg Fasted
n=6 Participants
Participants received single agent FGF401 80 mg while fasted
|
Phase I: 80 mg Fed
n=5 Participants
Participants received single agent FGF401 80 mg while fed
|
Phase I: 120 mg Fasted
n=26 Participants
Participants received single agent FGF401 120 mg while fasted
|
Phase I: 120 mg Fed
n=19 Participants
Participants received single agent FGF401 120 mg while fed
|
Phase I: 150 mg Fasted
n=7 Participants
Participants received single agent FGF401 150 mg while fasted
|
Phase I: FGF401 80 mg + PDR001 300 mg
Participants received FGF401 80 mg in combination with PDR001 300 mg while fasted
|
Phase I: FGF401 120 mg + PDR001 300 mg
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
|
Phase II: Group 1 - FGF401 120 mg QD
Group 1 was comprised of HCC participants from Asian contrives who took single agent FGF401 120 mg QD while fasted
|
Phase II: Group 2 - FGF401 120 mg QD
Group 2 was comprised of HCC participants from non-Asian countries who took single agent FGF401 120 mg QD while fasted
|
Phase I: FGF401 120 mg + PDR001 300 mg
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
|
All Patients of Combination Dose
These were all the participants in the Phase I part who received combination dose of FGF401 and PDR001
|
All Patients
Overall participants in the in Phase I \& Phase II of study
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUCinf, AUClast & AUCtau of FGF401: Phase I
AUCinf C1D8
|
—
|
3650 hr*ng/mL
Geometric Coefficient of Variation 71.9
|
5130 hr*ng/mL
Geometric Coefficient of Variation 28.9
|
5550 hr*ng/mL
Geometric Coefficient of Variation 23.2
|
7590 hr*ng/mL
Geometric Coefficient of Variation 43.0
|
7980 hr*ng/mL
Geometric Coefficient of Variation 25.1
|
7850 hr*ng/mL
Geometric Coefficient of Variation 29.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AUCinf, AUClast & AUCtau of FGF401: Phase I
AUCtau C1D8
|
—
|
3650 hr*ng/mL
Geometric Coefficient of Variation 65.6
|
4850 hr*ng/mL
Geometric Coefficient of Variation 27.0
|
5290 hr*ng/mL
Geometric Coefficient of Variation 24.0
|
6970 hr*ng/mL
Geometric Coefficient of Variation 38.7
|
7330 hr*ng/mL
Geometric Coefficient of Variation 26.7
|
7510 hr*ng/mL
Geometric Coefficient of Variation 29.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AUCinf, AUClast & AUCtau of FGF401: Phase I
AUCinf C2D1
|
—
|
4390 hr*ng/mL
Geometric Coefficient of Variation 54.0
|
4580 hr*ng/mL
Geometric Coefficient of Variation 30.6
|
5110 hr*ng/mL
Geometric Coefficient of Variation 44.3
|
7770 hr*ng/mL
Geometric Coefficient of Variation 33.2
|
8760 hr*ng/mL
Geometric Coefficient of Variation 23.5
|
7850 hr*ng/mL
Geometric Coefficient of Variation 25.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AUCinf, AUClast & AUCtau of FGF401: Phase I
AUClast C2D1
|
—
|
4100 hr*ng/mL
Geometric Coefficient of Variation 52.9
|
4210 hr*ng/mL
Geometric Coefficient of Variation 32.5
|
4880 hr*ng/mL
Geometric Coefficient of Variation 43.1
|
7260 hr*ng/mL
Geometric Coefficient of Variation 33.6
|
7520 hr*ng/mL
Geometric Coefficient of Variation 38.7
|
7610 hr*ng/mL
Geometric Coefficient of Variation 25.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AUCinf, AUClast & AUCtau of FGF401: Phase I
AUCinf C1D1
|
—
|
4920 hr*ng/mL
Geometric Coefficient of Variation 51.9
|
5090 hr*ng/mL
Geometric Coefficient of Variation 32.9
|
5560 hr*ng/mL
Geometric Coefficient of Variation 23.1
|
7210 hr*ng/mL
Geometric Coefficient of Variation 35.4
|
8520 hr*ng/mL
Geometric Coefficient of Variation 35.2
|
8190 hr*ng/mL
Geometric Coefficient of Variation 42.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AUCinf, AUClast & AUCtau of FGF401: Phase I
AUClast C1D1
|
—
|
4610 hr*ng/mL
Geometric Coefficient of Variation 50.4
|
4710 hr*ng/mL
Geometric Coefficient of Variation 38.0
|
4600 hr*ng/mL
Geometric Coefficient of Variation 39.2
|
6710 hr*ng/mL
Geometric Coefficient of Variation 35.6
|
7850 hr*ng/mL
Geometric Coefficient of Variation 34.1
|
7920 hr*ng/mL
Geometric Coefficient of Variation 42.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AUCinf, AUClast & AUCtau of FGF401: Phase I
AUCtau C1D1
|
—
|
4610 hr*ng/mL
Geometric Coefficient of Variation 50.4
|
4910 hr*ng/mL
Geometric Coefficient of Variation 30.3
|
4860 hr*ng/mL
Geometric Coefficient of Variation 29.4
|
6840 hr*ng/mL
Geometric Coefficient of Variation 33.6
|
8020 hr*ng/mL
Geometric Coefficient of Variation 33.5
|
7930 hr*ng/mL
Geometric Coefficient of Variation 41.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AUCinf, AUClast & AUCtau of FGF401: Phase I
AUClast C1D8
|
—
|
3460 hr*ng/mL
Geometric Coefficient of Variation 62.5
|
4840 hr*ng/mL
Geometric Coefficient of Variation 27.0
|
5280 hr*ng/mL
Geometric Coefficient of Variation 23.9
|
6480 hr*ng/mL
Geometric Coefficient of Variation 47.5
|
7640 hr*ng/mL
Geometric Coefficient of Variation 33.1
|
7550 hr*ng/mL
Geometric Coefficient of Variation 28.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AUCinf, AUClast & AUCtau of FGF401: Phase I
AUCtau C2D1
|
—
|
4100 hr*ng/mL
Geometric Coefficient of Variation 52.7
|
4360 hr*ng/mL
Geometric Coefficient of Variation 28.5
|
4870 hr*ng/mL
Geometric Coefficient of Variation 43.7
|
7330 hr*ng/mL
Geometric Coefficient of Variation 31.7
|
7830 hr*ng/mL
Geometric Coefficient of Variation 23.4
|
7620 hr*ng/mL
Geometric Coefficient of Variation 25.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: C1D1 (0h, 0.5h, 1h, 2h, 3h, 4h, 6h, 12h, 24h)Population: The PAS included all subjects who provided at least one evaluable drug concentration. For those requiring non-compartment analyses, the PAS included all subjects who provided an evaluable PK profile.
AUCinf: The AUC from time zero to infinity (mass x time x volume-1) AUClast: The AUC from time zero to the last measurable concentration sampling time (Tlast) (mass x time x volume-1) AUCtau: The AUC calculated to the end of a dosing interval (tau) (amount x time x volume-1)
Outcome measures
| Measure |
PhaseII: Group 3 - FGF401 120 mg QD
Group 3 was comprised of participants with other solid malignancies regardless of geography who took single agent FGF401 120 mg QD while fasted
|
Phase I: 50 mg Fasted
n=6 Participants
Participants received single agent FGF401 50 mg while fasted
|
Phase I: 80 mg Fasted
n=6 Participants
Participants received single agent FGF401 80 mg while fasted
|
Phase I: 80 mg Fed
Participants received single agent FGF401 80 mg while fed
|
Phase I: 120 mg Fasted
Participants received single agent FGF401 120 mg while fasted
|
Phase I: 120 mg Fed
Participants received single agent FGF401 120 mg while fed
|
Phase I: 150 mg Fasted
Participants received single agent FGF401 150 mg while fasted
|
Phase I: FGF401 80 mg + PDR001 300 mg
Participants received FGF401 80 mg in combination with PDR001 300 mg while fasted
|
Phase I: FGF401 120 mg + PDR001 300 mg
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
|
Phase II: Group 1 - FGF401 120 mg QD
Group 1 was comprised of HCC participants from Asian contrives who took single agent FGF401 120 mg QD while fasted
|
Phase II: Group 2 - FGF401 120 mg QD
Group 2 was comprised of HCC participants from non-Asian countries who took single agent FGF401 120 mg QD while fasted
|
Phase I: FGF401 120 mg + PDR001 300 mg
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
|
All Patients of Combination Dose
These were all the participants in the Phase I part who received combination dose of FGF401 and PDR001
|
All Patients
Overall participants in the in Phase I \& Phase II of study
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUCinf, AUClast & AUCtau of FGF401 in Combination With PDR001: Phase I
AUCinf
|
—
|
5030 hr*ng/mL
Geometric Coefficient of Variation 25.5
|
7540 hr*ng/mL
Geometric Coefficient of Variation 37.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AUCinf, AUClast & AUCtau of FGF401 in Combination With PDR001: Phase I
AUClast
|
—
|
4760 hr*ng/mL
Geometric Coefficient of Variation 25.0
|
7280 hr*ng/mL
Geometric Coefficient of Variation 36.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AUCinf, AUClast & AUCtau of FGF401 in Combination With PDR001: Phase I
AUCtau
|
—
|
4770 hr*ng/mL
Geometric Coefficient of Variation 24.4
|
7280 hr*ng/mL
Geometric Coefficient of Variation 36.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: C1D1 (0h, 0.5h, 1h, 2h, 3h, 4h, 6h, 12h, 24h), C1D8 (0h, 0.5h, 1h, 2h, 3h, 4h, 6h, 12h, 24h), and C2D1 (0h, 0.5h, 1h, 2h, 3h, 4h, 6h, 12h, 24h)Population: The PAS included all subjects who provided at least one evaluable drug concentration. For those requiring non-compartment analyses, the PAS included all subjects who provided an evaluable PK profile.
The elimination half-life associated with the terminal slope ( z) of a semi logarithmic concentration-time curve (time).
Outcome measures
| Measure |
PhaseII: Group 3 - FGF401 120 mg QD
Group 3 was comprised of participants with other solid malignancies regardless of geography who took single agent FGF401 120 mg QD while fasted
|
Phase I: 50 mg Fasted
n=10 Participants
Participants received single agent FGF401 50 mg while fasted
|
Phase I: 80 mg Fasted
n=6 Participants
Participants received single agent FGF401 80 mg while fasted
|
Phase I: 80 mg Fed
n=5 Participants
Participants received single agent FGF401 80 mg while fed
|
Phase I: 120 mg Fasted
n=26 Participants
Participants received single agent FGF401 120 mg while fasted
|
Phase I: 120 mg Fed
n=19 Participants
Participants received single agent FGF401 120 mg while fed
|
Phase I: 150 mg Fasted
n=7 Participants
Participants received single agent FGF401 150 mg while fasted
|
Phase I: FGF401 80 mg + PDR001 300 mg
Participants received FGF401 80 mg in combination with PDR001 300 mg while fasted
|
Phase I: FGF401 120 mg + PDR001 300 mg
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
|
Phase II: Group 1 - FGF401 120 mg QD
Group 1 was comprised of HCC participants from Asian contrives who took single agent FGF401 120 mg QD while fasted
|
Phase II: Group 2 - FGF401 120 mg QD
Group 2 was comprised of HCC participants from non-Asian countries who took single agent FGF401 120 mg QD while fasted
|
Phase I: FGF401 120 mg + PDR001 300 mg
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
|
All Patients of Combination Dose
These were all the participants in the Phase I part who received combination dose of FGF401 and PDR001
|
All Patients
Overall participants in the in Phase I \& Phase II of study
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
T1/2 of FGF401: Phase I
C1D1
|
—
|
6.27 hour (hr)
Geometric Coefficient of Variation 16.2
|
4.91 hour (hr)
Geometric Coefficient of Variation 31.6
|
5.2 hour (hr)
Geometric Coefficient of Variation 8.8
|
5.47 hour (hr)
Geometric Coefficient of Variation 14.4
|
5.16 hour (hr)
Geometric Coefficient of Variation 16.3
|
5 hour (hr)
Geometric Coefficient of Variation 11.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
T1/2 of FGF401: Phase I
C1D8
|
—
|
6.57 hour (hr)
Geometric Coefficient of Variation 16.6
|
6.08 hour (hr)
Geometric Coefficient of Variation 13.8
|
5.58 hour (hr)
Geometric Coefficient of Variation 12.0
|
5.43 hour (hr)
Geometric Coefficient of Variation 30.0
|
5.58 hour (hr)
Geometric Coefficient of Variation 17.1
|
5.24 hour (hr)
Geometric Coefficient of Variation 12.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
T1/2 of FGF401: Phase I
C2D1
|
—
|
6.46 hour (hr)
Geometric Coefficient of Variation 18.9
|
5.44 hour (hr)
Geometric Coefficient of Variation 34.9
|
5.43 hour (hr)
Geometric Coefficient of Variation 17.2
|
5.8 hour (hr)
Geometric Coefficient of Variation 22.1
|
5.81 hour (hr)
Geometric Coefficient of Variation 20.2
|
4.92 hour (hr)
Geometric Coefficient of Variation 14.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
POST_HOC outcome
Timeframe: approx. 135.3 weeks, approx. 4.5 yearsPopulation: FAS: The full analysis set (FAS) comprised all subjects who received at least one dose of study medication. Subjects enrolled in the Phase II part were analyzed by group.
This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of approx. 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination). Deaths post treatment survival follow up were collected after the on treatment period, up to approx. 4.5 years. Participants who had not died after study drug discontinuation were censored at the last date when the participant had some documented personal contact (visit or phone call) with the investigator.
Outcome measures
| Measure |
PhaseII: Group 3 - FGF401 120 mg QD
n=6 Participants
Group 3 was comprised of participants with other solid malignancies regardless of geography who took single agent FGF401 120 mg QD while fasted
|
Phase I: 50 mg Fasted
n=11 Participants
Participants received single agent FGF401 50 mg while fasted
|
Phase I: 80 mg Fasted
n=6 Participants
Participants received single agent FGF401 80 mg while fasted
|
Phase I: 80 mg Fed
n=5 Participants
Participants received single agent FGF401 80 mg while fed
|
Phase I: 120 mg Fasted
n=26 Participants
Participants received single agent FGF401 120 mg while fasted
|
Phase I: 120 mg Fed
n=19 Participants
Participants received single agent FGF401 120 mg while fed
|
Phase I: 150 mg Fasted
n=7 Participants
Participants received single agent FGF401 150 mg while fasted
|
Phase I: FGF401 80 mg + PDR001 300 mg
n=30 Participants
Participants received FGF401 80 mg in combination with PDR001 300 mg while fasted
|
Phase I: FGF401 120 mg + PDR001 300 mg
n=36 Participants
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
|
Phase II: Group 1 - FGF401 120 mg QD
n=20 Participants
Group 1 was comprised of HCC participants from Asian contrives who took single agent FGF401 120 mg QD while fasted
|
Phase II: Group 2 - FGF401 120 mg QD
n=160 Participants
Group 2 was comprised of HCC participants from non-Asian countries who took single agent FGF401 120 mg QD while fasted
|
Phase I: FGF401 120 mg + PDR001 300 mg
n=6 Participants
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
|
All Patients of Combination Dose
n=12 Participants
These were all the participants in the Phase I part who received combination dose of FGF401 and PDR001
|
All Patients
n=172 Participants
Overall participants in the in Phase I \& Phase II of study
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
All Collected Deaths
Total deaths
|
2 Participants
|
10 Participants
|
5 Participants
|
3 Participants
|
23 Participants
|
12 Participants
|
4 Participants
|
20 Participants
|
22 Participants
|
16 Participants
|
115 Participants
|
2 Participants
|
4 Participants
|
119 Participants
|
|
All Collected Deaths
Deaths on-treatment
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
6 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
20 Participants
|
0 Participants
|
0 Participants
|
20 Participants
|
|
All Collected Deaths
Deaths post-treatment survival follow up
|
2 Participants
|
8 Participants
|
4 Participants
|
3 Participants
|
19 Participants
|
6 Participants
|
3 Participants
|
18 Participants
|
20 Participants
|
14 Participants
|
95 Participants
|
2 Participants
|
4 Participants
|
99 Participants
|
Adverse Events
Phase I: 50 mg Fasted
Serious events: 3 serious events
Other events: 11 other events
Deaths: 2 deaths
Phase I: 80 mg Fasted
Serious events: 5 serious events
Other events: 6 other events
Deaths: 1 deaths
Phase I: 80 mg Fed
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Phase I: 120 mg Fasted
Serious events: 15 serious events
Other events: 26 other events
Deaths: 4 deaths
Phase I: 120 mg Fed
Serious events: 9 serious events
Other events: 19 other events
Deaths: 6 deaths
Phase I: 150 mg Fasted
Serious events: 3 serious events
Other events: 7 other events
Deaths: 1 deaths
Phase II: Group 1 - FGF401 120 mg QD
Serious events: 15 serious events
Other events: 29 other events
Deaths: 2 deaths
Phase II: Group 2 - FGF401 120 mg QD
Serious events: 9 serious events
Other events: 36 other events
Deaths: 2 deaths
Phase II: Group 3 - FGF401 120 mg QD
Serious events: 8 serious events
Other events: 20 other events
Deaths: 2 deaths
All Patients of Single Agent FGF401
Serious events: 70 serious events
Other events: 159 other events
Deaths: 20 deaths
Phase I: FGF401 80 mg + PDR001 300 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase I: FGF401 120 mg + PDR001 300 mg
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
All Patients of Combination Dose
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
All Patients
Serious events: 72 serious events
Other events: 171 other events
Deaths: 20 deaths
Serious adverse events
| Measure |
Phase I: 50 mg Fasted
n=11 participants at risk
Participants received single agent FGF401 50 mg while fasted
|
Phase I: 80 mg Fasted
n=6 participants at risk
Participants received single agent FGF401 80 mg while fasted
|
Phase I: 80 mg Fed
n=5 participants at risk
Participants received single agent FGF401 80 mg while fed
|
Phase I: 120 mg Fasted
n=26 participants at risk
Participants received single agent FGF401 120 mg while fasted
|
Phase I: 120 mg Fed
n=19 participants at risk
Participants received single agent FGF401 120 mg while fed
|
Phase I: 150 mg Fasted
n=7 participants at risk
Participants received single agent FGF401 150 mg while fasted
|
Phase II: Group 1 - FGF401 120 mg QD
n=30 participants at risk
Group 1 was comprised of HCC participants from Asian contrives who took single agent FGF401 120 mg QD while fasted
|
Phase II: Group 2 - FGF401 120 mg QD
n=36 participants at risk
Group 2 was comprised of HCC participants from non-Asian countries who took single agent FGF401 120 mg QD while fasted
|
Phase II: Group 3 - FGF401 120 mg QD
n=20 participants at risk
Group 3 was comprised of participants with other solid malignancies regardless of geography who took single agent FGF401 120 mg QD while fasted
|
All Patients of Single Agent FGF401
n=160 participants at risk
These were all the participants who received single dose of FGF401
|
Phase I: FGF401 80 mg + PDR001 300 mg
n=6 participants at risk
Participants received FGF401 80 mg in combination with PDR001 300 mg while fasted
|
Phase I: FGF401 120 mg + PDR001 300 mg
n=6 participants at risk
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
|
All Patients of Combination Dose
n=12 participants at risk
These were all the participants in the Phase I part who received combination dose of FGF401 and PDR001
|
All Patients
n=172 participants at risk
Overall participants in the in Phase I \& Phase II of study
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.3%
1/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.0%
1/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.3%
1/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.8%
1/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
20.0%
1/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.3%
1/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
20.0%
1/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
15.8%
3/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.6%
2/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
15.0%
3/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.6%
9/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.2%
9/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.8%
1/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.3%
1/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.3%
1/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.9%
3/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.7%
3/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Gastrointestinal disorders
Ascites
|
9.1%
1/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
20.0%
1/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
7.7%
2/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.3%
1/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.1%
5/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.9%
5/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.8%
1/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
33.3%
2/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
2/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.7%
3/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.0%
1/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.0%
1/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Gastrointestinal disorders
Gastric varices
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.3%
1/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
7.7%
2/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.8%
1/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.3%
1/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.8%
1/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.8%
1/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.9%
3/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.7%
3/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
9.1%
1/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
14.3%
1/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
8.3%
1/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.7%
3/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
9.1%
1/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.3%
1/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.9%
3/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.7%
3/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.0%
1/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
General disorders
Asthenia
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.3%
1/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
General disorders
Chest discomfort
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.3%
1/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
General disorders
Fatigue
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.3%
1/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
General disorders
Gait disturbance
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.0%
1/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.8%
1/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
General disorders
Oedema peripheral
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.8%
1/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
General disorders
Pyrexia
|
9.1%
1/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
10.0%
2/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.9%
3/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
33.3%
2/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
2/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.9%
5/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Hepatobiliary disorders
Biloma
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
20.0%
1/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.8%
1/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.3%
1/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.8%
1/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.8%
1/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Hepatobiliary disorders
Hepatic haematoma
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.8%
1/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.8%
1/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.8%
1/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.3%
1/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Infections and infestations
Lung infection
|
9.1%
1/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.8%
1/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.8%
1/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.8%
1/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.3%
1/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Infections and infestations
Varicella
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.0%
1/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.3%
1/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
14.3%
1/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.3%
1/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
28.6%
2/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.3%
1/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.9%
3/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.7%
3/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.8%
1/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.3%
1/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
8.3%
1/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
7.7%
2/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.6%
2/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liver carcinoma ruptured
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.8%
1/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
8.3%
1/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
14.3%
1/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour thrombosis
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.8%
1/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.3%
1/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Nervous system disorders
Dysarthria
|
9.1%
1/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.8%
1/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Nervous system disorders
Paraparesis
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.3%
1/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Nervous system disorders
Paraplegia
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.0%
1/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
7.7%
2/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.0%
1/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.0%
1/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.3%
1/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
20.0%
1/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchostenosis
|
9.1%
1/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.8%
1/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.3%
1/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.3%
1/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
14.3%
1/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.3%
1/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.0%
1/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.5%
4/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.3%
4/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
7.7%
2/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.8%
1/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.0%
1/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.3%
1/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Vascular disorders
Aneurysm
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.8%
1/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Vascular disorders
Bleeding varicose vein
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.3%
1/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.8%
1/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Vascular disorders
Inferior vena caval occlusion
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.8%
1/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.3%
1/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
Other adverse events
| Measure |
Phase I: 50 mg Fasted
n=11 participants at risk
Participants received single agent FGF401 50 mg while fasted
|
Phase I: 80 mg Fasted
n=6 participants at risk
Participants received single agent FGF401 80 mg while fasted
|
Phase I: 80 mg Fed
n=5 participants at risk
Participants received single agent FGF401 80 mg while fed
|
Phase I: 120 mg Fasted
n=26 participants at risk
Participants received single agent FGF401 120 mg while fasted
|
Phase I: 120 mg Fed
n=19 participants at risk
Participants received single agent FGF401 120 mg while fed
|
Phase I: 150 mg Fasted
n=7 participants at risk
Participants received single agent FGF401 150 mg while fasted
|
Phase II: Group 1 - FGF401 120 mg QD
n=30 participants at risk
Group 1 was comprised of HCC participants from Asian contrives who took single agent FGF401 120 mg QD while fasted
|
Phase II: Group 2 - FGF401 120 mg QD
n=36 participants at risk
Group 2 was comprised of HCC participants from non-Asian countries who took single agent FGF401 120 mg QD while fasted
|
Phase II: Group 3 - FGF401 120 mg QD
n=20 participants at risk
Group 3 was comprised of participants with other solid malignancies regardless of geography who took single agent FGF401 120 mg QD while fasted
|
All Patients of Single Agent FGF401
n=160 participants at risk
These were all the participants who received single dose of FGF401
|
Phase I: FGF401 80 mg + PDR001 300 mg
n=6 participants at risk
Participants received FGF401 80 mg in combination with PDR001 300 mg while fasted
|
Phase I: FGF401 120 mg + PDR001 300 mg
n=6 participants at risk
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
|
All Patients of Combination Dose
n=12 participants at risk
These were all the participants in the Phase I part who received combination dose of FGF401 and PDR001
|
All Patients
n=172 participants at risk
Overall participants in the in Phase I \& Phase II of study
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
9.1%
1/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
11.5%
3/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
10.5%
2/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
14.3%
1/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
5/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.8%
1/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
25.0%
5/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
11.2%
18/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
33.3%
2/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
33.3%
2/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
33.3%
4/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
12.8%
22/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Blood and lymphatic system disorders
Hyperglobulinaemia
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
14.3%
1/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.8%
1/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.3%
1/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
14.3%
1/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.9%
3/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.7%
3/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
7.7%
2/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.8%
1/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.3%
1/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
20.0%
1/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
8.3%
1/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
8.3%
1/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
20.0%
1/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.3%
1/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
8.3%
1/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.7%
3/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Gastrointestinal disorders
Abdominal distension
|
9.1%
1/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
20.0%
1/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
11.5%
3/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
42.9%
3/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
10.0%
3/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.8%
1/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.0%
1/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
8.1%
13/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
50.0%
3/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
25.0%
3/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
9.3%
16/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
60.0%
3/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
11.5%
3/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
21.1%
4/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
5/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
6/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
45.0%
9/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
19.4%
31/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
33.3%
2/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
2/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
19.2%
33/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.1%
1/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
26.9%
7/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.3%
1/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
5/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
13.9%
5/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.0%
1/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
13.1%
21/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
12.2%
21/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
9.1%
1/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Gastrointestinal disorders
Angular cheilitis
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.3%
1/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
40.0%
2/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
19.2%
5/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
28.6%
2/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
13.3%
4/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
8.3%
3/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
10.0%
2/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
11.9%
19/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
11.0%
19/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Gastrointestinal disorders
Constipation
|
9.1%
1/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
20.0%
1/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
15.4%
4/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.3%
1/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
5/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
13.9%
5/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
30.0%
6/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
14.4%
23/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
8.3%
1/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
14.0%
24/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Gastrointestinal disorders
Diarrhoea
|
72.7%
8/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
66.7%
4/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
80.0%
4/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
69.2%
18/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
73.7%
14/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
100.0%
7/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
76.7%
23/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
63.9%
23/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
85.0%
17/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
73.8%
118/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
50.0%
3/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
66.7%
4/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
58.3%
7/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
72.7%
125/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Gastrointestinal disorders
Dry mouth
|
9.1%
1/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
8.3%
3/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.0%
1/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.1%
5/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.9%
5/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
9.1%
1/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.8%
1/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.3%
1/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.9%
3/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.7%
3/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
11.1%
4/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.5%
4/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.3%
4/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Gastrointestinal disorders
Dysphagia
|
9.1%
1/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.3%
1/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.6%
2/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.0%
1/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.1%
5/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.9%
5/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.3%
1/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
14.3%
1/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.8%
1/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
15.4%
4/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.8%
1/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.0%
1/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.8%
6/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.5%
6/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
10.0%
2/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.8%
1/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
14.3%
1/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
6.7%
2/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.5%
4/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.3%
4/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Gastrointestinal disorders
Nausea
|
9.1%
1/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
19.2%
5/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
31.6%
6/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
14.3%
1/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
23.3%
7/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
6/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
55.0%
11/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
23.8%
38/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
33.3%
2/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
2/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
23.3%
40/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
9.1%
1/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
9.1%
1/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
9.1%
1/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Gastrointestinal disorders
Stomatitis
|
18.2%
2/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.3%
1/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.8%
1/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.5%
4/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.3%
4/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.8%
1/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.3%
1/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Gastrointestinal disorders
Varices oesophageal
|
9.1%
1/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
1/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
20.0%
1/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
15.4%
4/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
31.6%
6/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
14.3%
1/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
5/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
11.1%
4/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
45.0%
9/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
20.0%
32/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
8.3%
1/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
19.2%
33/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
General disorders
Asthenia
|
18.2%
2/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
33.3%
2/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
15.4%
4/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
15.8%
3/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
28.6%
2/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
10.0%
3/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
6/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
20.0%
4/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.2%
26/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
15.1%
26/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
General disorders
Chest discomfort
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
6.7%
2/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
General disorders
Chills
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.8%
1/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
10.0%
3/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.0%
1/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.1%
5/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.9%
5/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
General disorders
Fatigue
|
18.2%
2/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
23.1%
6/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
21.1%
4/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
6.7%
2/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
22.2%
8/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
35.0%
7/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
18.8%
30/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
33.3%
2/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
25.0%
3/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
19.2%
33/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
General disorders
General physical health deterioration
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.6%
2/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
General disorders
Hernia
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
14.3%
1/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
General disorders
Malaise
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
7.7%
2/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.8%
1/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.9%
3/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.7%
3/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
General disorders
Oedema
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.8%
1/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.8%
1/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
8.3%
1/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.7%
3/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
General disorders
Oedema peripheral
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
34.6%
9/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
26.7%
8/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
25.0%
9/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
15.0%
3/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
18.8%
30/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
33.3%
2/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
2/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
18.6%
32/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
General disorders
Pain
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
14.3%
1/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.6%
2/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.0%
1/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.5%
4/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.3%
4/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
General disorders
Peripheral swelling
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.3%
1/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
14.3%
1/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.3%
1/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.9%
3/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.7%
3/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
General disorders
Pyrexia
|
27.3%
3/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
40.0%
2/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
23.1%
6/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.3%
1/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
14.3%
1/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
30.0%
9/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
11.1%
4/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
25.0%
5/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
19.4%
31/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
50.0%
3/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
33.3%
4/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
20.3%
35/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
9.1%
1/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
20.0%
1/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.8%
1/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.6%
2/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.0%
1/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.1%
5/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.9%
5/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Hepatobiliary disorders
Hepatocellular injury
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
20.0%
1/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.8%
1/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.0%
1/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.9%
3/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.7%
3/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
7.7%
2/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
9.1%
1/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.8%
1/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.3%
1/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.0%
1/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.9%
3/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.7%
3/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
6.7%
2/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.8%
1/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.9%
3/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.7%
3/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.3%
1/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.3%
1/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.8%
1/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.0%
1/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.9%
3/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.7%
3/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Infections and infestations
Candida infection
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
8.3%
1/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.6%
2/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.3%
1/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.0%
1/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.3%
1/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
14.3%
1/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.3%
1/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.6%
2/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.1%
5/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
33.3%
2/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
2/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
4.1%
7/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.8%
1/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
6.7%
2/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.8%
1/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.5%
4/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.3%
4/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.8%
1/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
8.3%
1/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
7.7%
2/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.3%
1/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.8%
1/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.0%
1/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.1%
5/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.9%
5/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
8.3%
1/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Infections and infestations
Tinea cruris
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
8.3%
1/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
20.0%
1/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
7.7%
2/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.8%
1/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.5%
4/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.3%
4/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.3%
1/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.3%
1/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.8%
1/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
5/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.0%
1/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
4.4%
7/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
4.1%
7/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
9.1%
1/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.0%
1/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Investigations
Alanine aminotransferase increased
|
27.3%
3/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
50.0%
3/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
40.0%
2/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
53.8%
14/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
57.9%
11/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
100.0%
7/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
43.3%
13/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
30.6%
11/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
30.0%
6/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
43.8%
70/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
66.7%
4/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
33.3%
4/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
43.0%
74/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Investigations
Amylase increased
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.3%
1/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.6%
2/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.5%
4/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.3%
4/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Investigations
Aspartate aminotransferase increased
|
36.4%
4/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
50.0%
3/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
40.0%
2/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
61.5%
16/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
73.7%
14/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
100.0%
7/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
46.7%
14/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
30.6%
11/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
25.0%
5/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
47.5%
76/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
83.3%
5/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
50.0%
6/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
47.7%
82/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
8.3%
1/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Investigations
Blood albumin decreased
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
8.3%
1/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Investigations
Blood alkaline phosphatase increased
|
9.1%
1/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
20.0%
1/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
15.4%
4/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
26.3%
5/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
14.3%
1/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
13.3%
4/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.6%
2/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
10.0%
2/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
12.5%
20/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
8.3%
1/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
12.2%
21/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Investigations
Blood bilirubin increased
|
36.4%
4/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
50.0%
3/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
20.0%
1/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
42.3%
11/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
10.5%
2/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
20.0%
6/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
8.3%
3/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.0%
1/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
19.4%
31/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
33.3%
2/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
25.0%
3/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
19.8%
34/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.3%
1/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.8%
1/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
10.5%
2/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.8%
1/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.1%
5/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
8.3%
1/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.5%
6/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
20.0%
1/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
7.7%
2/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.8%
1/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.5%
4/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
8.3%
1/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.9%
5/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
8.3%
1/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
7.7%
2/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.8%
1/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.9%
3/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.7%
3/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
15.4%
4/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
10.5%
2/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
13.3%
4/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
8.3%
3/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
15.0%
3/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
10.6%
17/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
2/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
11.0%
19/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Investigations
Haemoglobin decreased
|
9.1%
1/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Investigations
Lipase increased
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
20.0%
1/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.8%
1/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
13.3%
4/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
6/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.0%
1/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
8.8%
14/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
8.1%
14/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
6.7%
2/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
33.3%
2/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
2/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.3%
4/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Investigations
Platelet count decreased
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
20.0%
1/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
6.7%
2/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.6%
2/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.0%
1/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.8%
6/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
8.3%
1/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
4.1%
7/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Investigations
Prothrombin time prolonged
|
9.1%
1/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Investigations
Transaminases increased
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.3%
1/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.8%
1/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.0%
1/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.9%
3/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.7%
3/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Investigations
Weight decreased
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.8%
1/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
10.5%
2/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
14.3%
1/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
11.1%
4/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
20.0%
4/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
7.5%
12/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
8.3%
1/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
7.6%
13/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
27.3%
3/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
38.5%
10/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
10.5%
2/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
57.1%
4/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
20.0%
6/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
25.0%
9/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
60.0%
12/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
29.4%
47/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
27.3%
47/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
9.1%
1/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.8%
1/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.0%
1/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.5%
4/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.3%
4/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
20.0%
1/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.8%
1/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.3%
1/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.3%
1/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.8%
1/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.1%
5/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.9%
5/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
20.0%
1/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.8%
1/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.8%
1/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.9%
3/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.7%
3/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Metabolism and nutrition disorders
Hyperlipasaemia
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
20.0%
1/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
7.7%
2/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.6%
2/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.8%
6/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.5%
6/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
14.3%
1/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
10.0%
3/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.8%
1/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
10.0%
2/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.0%
8/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
33.3%
2/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
50.0%
3/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
41.7%
5/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
7.6%
13/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
9.1%
1/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
7.7%
2/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.9%
3/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.7%
3/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
7.7%
2/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
9.1%
1/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
11.5%
3/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
23.3%
7/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.8%
1/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
10.0%
2/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
8.8%
14/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
8.1%
14/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
11.5%
3/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
14.3%
1/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.8%
1/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.1%
5/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
8.3%
1/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.5%
6/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.3%
1/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
20.0%
1/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
11.5%
3/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
10.5%
2/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
4.4%
7/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
8.3%
1/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
4.7%
8/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.3%
1/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.3%
1/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.0%
1/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.9%
3/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.7%
3/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.8%
1/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
14.3%
1/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.6%
2/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.0%
1/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.9%
3/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
2/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.9%
5/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
7.7%
2/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
14.3%
1/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
5/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
11.1%
4/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.0%
1/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
8.8%
14/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
33.3%
2/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
2/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
9.3%
16/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.3%
1/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
6.7%
2/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.9%
3/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
8.3%
1/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.3%
4/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.3%
1/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.6%
2/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.0%
1/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.9%
3/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.7%
3/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
14.3%
1/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.3%
1/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.0%
1/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.9%
3/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.7%
3/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
11.5%
3/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.3%
1/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
10.0%
3/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.6%
2/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
15.0%
3/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
7.5%
12/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
7.0%
12/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
10.0%
3/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.0%
1/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.5%
4/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
8.3%
1/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.9%
5/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.6%
2/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
6.7%
2/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.9%
3/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.7%
3/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
9.1%
1/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
14.3%
1/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.3%
1/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
6.7%
2/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.9%
3/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.7%
3/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Nervous system disorders
Dysgeusia
|
27.3%
3/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.3%
1/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.8%
1/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.0%
1/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.8%
6/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
8.3%
1/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
4.1%
7/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Nervous system disorders
Headache
|
9.1%
1/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
20.0%
1/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
13.3%
4/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
8.3%
3/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
15.0%
3/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
7.5%
12/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
8.3%
1/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
7.6%
13/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
8.3%
1/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.3%
1/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Nervous system disorders
Visual field defect
|
9.1%
1/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.3%
1/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.6%
2/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.0%
1/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.1%
5/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.9%
5/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Psychiatric disorders
Depression
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.3%
1/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.8%
1/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
20.0%
1/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.8%
1/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.3%
1/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
28.6%
2/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
13.3%
4/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.6%
2/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
25.0%
5/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
10.0%
16/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
8.3%
1/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
9.9%
17/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.6%
2/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.3%
1/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.8%
1/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
14.3%
1/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Reproductive system and breast disorders
Varicocele
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.3%
1/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchostenosis
|
9.1%
1/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
1/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
7.7%
2/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
10.5%
2/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
28.6%
2/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
23.3%
7/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
8.3%
3/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
10.0%
2/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
11.9%
19/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
8.3%
1/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
11.6%
20/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.8%
1/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.0%
1/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
8.3%
1/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.7%
3/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.1%
1/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
20.0%
1/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
11.5%
3/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
14.3%
1/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
13.3%
4/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
8.3%
3/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
15.0%
3/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
10.6%
17/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
9.9%
17/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.8%
1/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
8.3%
1/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.3%
1/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.0%
1/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
8.3%
1/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.7%
3/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
20.0%
1/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
14.3%
1/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
10.0%
3/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.1%
5/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.9%
5/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
14.3%
1/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
6.7%
2/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.8%
1/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.5%
4/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.3%
4/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.8%
1/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
10.0%
2/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.9%
3/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.7%
3/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.3%
1/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
8.3%
1/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.8%
1/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
11.1%
4/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
10.0%
2/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
4.4%
7/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
8.3%
1/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
4.7%
8/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
9.1%
1/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.8%
1/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
10.0%
3/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
2.8%
1/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.8%
6/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
8.3%
1/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
4.1%
7/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
8.3%
3/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.9%
3/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.7%
3/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
18.2%
2/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
33.3%
2/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
20.0%
1/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
15.4%
4/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
26.3%
5/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
14.3%
1/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
5/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
22.2%
8/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
17.5%
28/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
33.3%
2/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
2/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
17.4%
30/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.1%
1/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
14.3%
1/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.3%
1/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
10.0%
2/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.8%
6/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
33.3%
2/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
2/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
4.7%
8/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
9.1%
1/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.3%
1/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Vascular disorders
Haematoma
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.6%
2/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Vascular disorders
Hot flush
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
2/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
1.2%
2/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Vascular disorders
Hypertension
|
0.00%
0/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
16.7%
1/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
3.8%
1/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
28.6%
2/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
8.3%
3/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
10.0%
2/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.6%
9/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
5.2%
9/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
|
Vascular disorders
Vena cava thrombosis
|
9.1%
1/11 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/5 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/26 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/19 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/7 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/30 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/36 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/20 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.62%
1/160 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/6 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.00%
0/12 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
0.58%
1/172 • This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER