Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma (NCT NCT03656536)
NCT ID: NCT03656536
Last Updated: 2026-08-11
Results Overview
PFS was defined as the time from the date of the first dose of study drug after transition until the earliest date of progressive disease or death due to any cause.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
167 participants
Primary outcome timeframe
up to 1496 days
Results posted on
2026-08-11
Participant Flow
This study was conducted at 79 study centers in 14 countries.
Participant milestones
| Measure |
Pemigatinib 13.5 mg QD
Participants received oral pemigatinib 13.5 milligrams (mg) once daily (QD) continuous therapy in 3-week cycles. Treatment continued until disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) assessed by Independent Central Review (ICR), unacceptable toxicity, or another treatment discontinuation criterion was met.
|
Gemcitabine 1000 mg/m^2 Plus Cisplatin 25 mg/m^2 to Pemigatinib 13.5 mg QD
Participants received gemcitabine 1000 milligrams per square meter (mg/m\^2) plus cisplatin 25 mg/m\^2 intravenously on Days 1 and 8 every 3 weeks for up to 8 cycles (if 1 cycle was administered prior to randomization, the total of 8 cycles included that prior cycle as well). If disease progression occurred per RECIST v1.1 assessed by ICR, a transition to pemigatinib 13.5 mg QD was allowed.
|
|---|---|---|
|
Randomized Treatment Period
STARTED
|
83
|
84
|
|
Randomized Treatment Period
COMPLETED
|
0
|
0
|
|
Randomized Treatment Period
NOT COMPLETED
|
83
|
84
|
|
Transition Period
STARTED
|
0
|
42
|
|
Transition Period
COMPLETED
|
0
|
0
|
|
Transition Period
NOT COMPLETED
|
0
|
42
|
Reasons for withdrawal
| Measure |
Pemigatinib 13.5 mg QD
Participants received oral pemigatinib 13.5 milligrams (mg) once daily (QD) continuous therapy in 3-week cycles. Treatment continued until disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) assessed by Independent Central Review (ICR), unacceptable toxicity, or another treatment discontinuation criterion was met.
|
Gemcitabine 1000 mg/m^2 Plus Cisplatin 25 mg/m^2 to Pemigatinib 13.5 mg QD
Participants received gemcitabine 1000 milligrams per square meter (mg/m\^2) plus cisplatin 25 mg/m\^2 intravenously on Days 1 and 8 every 3 weeks for up to 8 cycles (if 1 cycle was administered prior to randomization, the total of 8 cycles included that prior cycle as well). If disease progression occurred per RECIST v1.1 assessed by ICR, a transition to pemigatinib 13.5 mg QD was allowed.
|
|---|---|---|
|
Randomized Treatment Period
Death
|
51
|
20
|
|
Randomized Treatment Period
Study Terminated by Sponsor
|
26
|
9
|
|
Randomized Treatment Period
Withdrawal by Subject
|
5
|
12
|
|
Randomized Treatment Period
Disease Progression
|
1
|
0
|
|
Randomized Treatment Period
Physician Decision: Worsening of Clinical Condition
|
0
|
1
|
|
Randomized Treatment Period
Transitioned to pemigatinib
|
0
|
42
|
|
Transition Period
Death
|
0
|
27
|
|
Transition Period
Lost to Follow-up
|
0
|
2
|
|
Transition Period
Study Terminated by Sponsor
|
0
|
11
|
|
Transition Period
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma
Baseline characteristics by cohort
| Measure |
Pemigatinib 13.5 mg QD
n=83 Participants
Participants received oral pemigatinib 13.5 milligrams (mg) once daily (QD) continuous therapy in 3-week cycles. Treatment continued until disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) assessed by Independent Central Review (ICR), unacceptable toxicity, or another treatment discontinuation criterion was met.
|
Gemcitabine 1000 mg/m^2 Plus Cisplatin 25 mg/m^2 to Pemigatinib 13.5 mg QD
n=84 Participants
Participants received gemcitabine 1000 milligrams per square meter (mg/m\^2) plus cisplatin 25 mg/m\^2 intravenously on Days 1 and 8 every 3 weeks for up to 8 cycles (if 1 cycle was administered prior to randomization, the total of 8 cycles included that prior cycle as well). If disease progression occurred per RECIST v1.1 assessed by ICR, a transition to pemigatinib 13.5 mg QD was allowed.
|
Total
n=167 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
59.4 years
STANDARD_DEVIATION 13.05 • n=54 Participants
|
57.2 years
STANDARD_DEVIATION 12.45 • n=54 Participants
|
58.3 years
STANDARD_DEVIATION 12.76 • n=27 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=54 Participants
|
51 Participants
n=54 Participants
|
97 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=54 Participants
|
33 Participants
n=54 Participants
|
70 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
60 Participants
n=54 Participants
|
57 Participants
n=54 Participants
|
117 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
5 Participants
n=54 Participants
|
3 Participants
n=54 Participants
|
8 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
11 Participants
n=54 Participants
|
17 Participants
n=54 Participants
|
28 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
10 Participants
n=54 Participants
|
14 Participants
n=54 Participants
|
24 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Captured as "Hispanic" in the Database
|
1 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian - Indian
|
0 Participants
n=54 Participants
|
1 Participants
n=54 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Egyptian
|
0 Participants
n=54 Participants
|
1 Participants
n=54 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
4 Participants
n=54 Participants
|
3 Participants
n=54 Participants
|
7 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
66 Participants
n=54 Participants
|
61 Participants
n=54 Participants
|
127 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
2 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
2 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Captured as "Other" in Database
|
1 Participants
n=54 Participants
|
6 Participants
n=54 Participants
|
7 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: up to 1422 daysPopulation: Intent-to-Treat (ITT) Population: all randomized participants. Treatment groups were defined according to the treatment assignment at the time of randomization. Median survival time was estimated using the Kaplan-Meier method. The 95% confidence intervals (Cis) were calculated with the Brookmeyer and Crowley method (log-log transformation).
PFS was defined as the time from the date of randomization until the date of disease progression (according to Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST v1.1\] and assessed by an Independent Central Review \[ICR\]) or death, whichever occurs first.
Outcome measures
| Measure |
Pemigatinib 13.5 mg QD
n=83 Participants
Participants received oral pemigatinib 13.5 milligrams (mg) once daily (QD) continuous therapy in 3-week cycles. Treatment continued until disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) assessed by Independent Central Review (ICR), unacceptable toxicity, or another treatment discontinuation criterion was met.
|
Gemcitabine 1000 mg/m^2 Plus Cisplatin 25 mg/m^2 to Pemigatinib 13.5 mg QD
n=84 Participants
Participants received gemcitabine 1000 milligrams per square meter (mg/m\^2) plus cisplatin 25 mg/m\^2 intravenously on Days 1 and 8 every 3 weeks for up to 8 cycles (if 1 cycle was administered prior to randomization, the total of 8 cycles included that prior cycle as well). If disease progression occurred per RECIST v1.1 assessed by ICR, a transition to pemigatinib 13.5 mg QD was allowed.
|
|---|---|---|
|
Randomized Treatment Period: Progression-free Survival (PFS)
|
8.34 months
Interval 6.51 to 12.22
|
6.80 months
Interval 6.05 to 8.25
|
PRIMARY outcome
Timeframe: up to 1422 daysPopulation: ITT Population. The number of participants analyzed for the Kaplan-Meier estimate at each time point refers to the total number of participants in the analysis set.
PFS was defined as the time from the date of randomization until the date of disease progression (according to RECIST v1.1 and assessed by an ICR) or death, whichever occurs first. Kaplan-Meier estimates indicate the percent probability of a participant being alive at the indicated time after treatment start.
Outcome measures
| Measure |
Pemigatinib 13.5 mg QD
n=83 Participants
Participants received oral pemigatinib 13.5 milligrams (mg) once daily (QD) continuous therapy in 3-week cycles. Treatment continued until disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) assessed by Independent Central Review (ICR), unacceptable toxicity, or another treatment discontinuation criterion was met.
|
Gemcitabine 1000 mg/m^2 Plus Cisplatin 25 mg/m^2 to Pemigatinib 13.5 mg QD
n=84 Participants
Participants received gemcitabine 1000 milligrams per square meter (mg/m\^2) plus cisplatin 25 mg/m\^2 intravenously on Days 1 and 8 every 3 weeks for up to 8 cycles (if 1 cycle was administered prior to randomization, the total of 8 cycles included that prior cycle as well). If disease progression occurred per RECIST v1.1 assessed by ICR, a transition to pemigatinib 13.5 mg QD was allowed.
|
|---|---|---|
|
Randomized Treatment Period: Kaplan-Meier Estimates of PFS of the Indicated Lengths of Time
3 months
|
90.0 percent probability
Interval 81.0 to 94.9
|
77.8 percent probability
Interval 66.3 to 85.7
|
|
Randomized Treatment Period: Kaplan-Meier Estimates of PFS of the Indicated Lengths of Time
6 months
|
68.8 percent probability
Interval 57.1 to 77.9
|
64.3 percent probability
Interval 51.9 to 74.3
|
|
Randomized Treatment Period: Kaplan-Meier Estimates of PFS of the Indicated Lengths of Time
9 months
|
44.6 percent probability
Interval 32.7 to 55.8
|
26.5 percent probability
Interval 16.0 to 38.2
|
|
Randomized Treatment Period: Kaplan-Meier Estimates of PFS of the Indicated Lengths of Time
12 months
|
39.1 percent probability
Interval 27.3 to 50.6
|
17.1 percent probability
Interval 8.6 to 27.9
|
|
Randomized Treatment Period: Kaplan-Meier Estimates of PFS of the Indicated Lengths of Time
24 months
|
20.9 percent probability
Interval 10.8 to 33.2
|
8.5 percent probability
Interval 2.2 to 20.2
|
|
Randomized Treatment Period: Kaplan-Meier Estimates of PFS of the Indicated Lengths of Time
36 months
|
11.6 percent probability
Interval 3.1 to 26.4
|
8.5 percent probability
Interval 2.2 to 20.2
|
PRIMARY outcome
Timeframe: up to 1496 daysPopulation: Crossover Evaluable Population: all participants who received at least 1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group
PFS was defined as the time from the date of the first dose of study drug after transition until the earliest date of progressive disease or death due to any cause.
Outcome measures
| Measure |
Pemigatinib 13.5 mg QD
n=42 Participants
Participants received oral pemigatinib 13.5 milligrams (mg) once daily (QD) continuous therapy in 3-week cycles. Treatment continued until disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) assessed by Independent Central Review (ICR), unacceptable toxicity, or another treatment discontinuation criterion was met.
|
Gemcitabine 1000 mg/m^2 Plus Cisplatin 25 mg/m^2 to Pemigatinib 13.5 mg QD
Participants received gemcitabine 1000 milligrams per square meter (mg/m\^2) plus cisplatin 25 mg/m\^2 intravenously on Days 1 and 8 every 3 weeks for up to 8 cycles (if 1 cycle was administered prior to randomization, the total of 8 cycles included that prior cycle as well). If disease progression occurred per RECIST v1.1 assessed by ICR, a transition to pemigatinib 13.5 mg QD was allowed.
|
|---|---|---|
|
Transition Period: PFS
|
8.08 months
Interval 4.44 to 9.89
|
—
|
PRIMARY outcome
Timeframe: up to 1496 daysPopulation: Crossover Evaluable Population. The number of participants analyzed for the Kaplan-Meier estimate at each time point refers to the total number of participants in the analysis set.
PFS was defined as the time from the date of the first dose of study drug after transition until the earliest date of progressive disease or death due to any cause. Kaplan-Meier estimates indicate the percent probability of a participant being alive at the indicated time after treatment start.
Outcome measures
| Measure |
Pemigatinib 13.5 mg QD
n=42 Participants
Participants received oral pemigatinib 13.5 milligrams (mg) once daily (QD) continuous therapy in 3-week cycles. Treatment continued until disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) assessed by Independent Central Review (ICR), unacceptable toxicity, or another treatment discontinuation criterion was met.
|
Gemcitabine 1000 mg/m^2 Plus Cisplatin 25 mg/m^2 to Pemigatinib 13.5 mg QD
Participants received gemcitabine 1000 milligrams per square meter (mg/m\^2) plus cisplatin 25 mg/m\^2 intravenously on Days 1 and 8 every 3 weeks for up to 8 cycles (if 1 cycle was administered prior to randomization, the total of 8 cycles included that prior cycle as well). If disease progression occurred per RECIST v1.1 assessed by ICR, a transition to pemigatinib 13.5 mg QD was allowed.
|
|---|---|---|
|
Transition Period: Kaplan-Meier Estimates of PFS of the Indicated Lengths of Time
3 months
|
87.6 percent probability
Interval 72.6 to 94.6
|
—
|
|
Transition Period: Kaplan-Meier Estimates of PFS of the Indicated Lengths of Time
6 months
|
62.4 percent probability
Interval 45.6 to 75.4
|
—
|
|
Transition Period: Kaplan-Meier Estimates of PFS of the Indicated Lengths of Time
9 months
|
39.7 percent probability
Interval 24.2 to 54.9
|
—
|
|
Transition Period: Kaplan-Meier Estimates of PFS of the Indicated Lengths of Time
12 months
|
12.6 percent probability
Interval 3.6 to 27.3
|
—
|
|
Transition Period: Kaplan-Meier Estimates of PFS of the Indicated Lengths of Time
24 months
|
4.2 percent probability
Interval 0.3 to 17.2
|
—
|
|
Transition Period: Kaplan-Meier Estimates of PFS of the Indicated Lengths of Time
36 months
|
0.0 percent probability
The upper and lower limits of the confidence interval were not estimable because no participants were still being followed without disease progression.
|
—
|
SECONDARY outcome
Timeframe: up to 1422 daysPopulation: ITT Population. The confidence intervals were calculated based on the exact method for binomial distribution.
ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) per RECIST v1.1 as assessed by an ICR. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
Outcome measures
| Measure |
Pemigatinib 13.5 mg QD
n=83 Participants
Participants received oral pemigatinib 13.5 milligrams (mg) once daily (QD) continuous therapy in 3-week cycles. Treatment continued until disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) assessed by Independent Central Review (ICR), unacceptable toxicity, or another treatment discontinuation criterion was met.
|
Gemcitabine 1000 mg/m^2 Plus Cisplatin 25 mg/m^2 to Pemigatinib 13.5 mg QD
n=84 Participants
Participants received gemcitabine 1000 milligrams per square meter (mg/m\^2) plus cisplatin 25 mg/m\^2 intravenously on Days 1 and 8 every 3 weeks for up to 8 cycles (if 1 cycle was administered prior to randomization, the total of 8 cycles included that prior cycle as well). If disease progression occurred per RECIST v1.1 assessed by ICR, a transition to pemigatinib 13.5 mg QD was allowed.
|
|---|---|---|
|
Randomized Treatment Period: Objective Response Rate (ORR)
|
47.0 percentage of participants
Interval 35.93 to 58.26
|
15.5 percentage of participants
Interval 8.51 to 25.01
|
SECONDARY outcome
Timeframe: up to 1496 daysPopulation: Crossover Evaluable Population. The confidence interval was calculated based on the exact method for binomial distribution.
ORR was defined as the percentage of participants with a best overall response of CR or PR per RECIST v1.1 as assessed by an ICR. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
Outcome measures
| Measure |
Pemigatinib 13.5 mg QD
n=42 Participants
Participants received oral pemigatinib 13.5 milligrams (mg) once daily (QD) continuous therapy in 3-week cycles. Treatment continued until disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) assessed by Independent Central Review (ICR), unacceptable toxicity, or another treatment discontinuation criterion was met.
|
Gemcitabine 1000 mg/m^2 Plus Cisplatin 25 mg/m^2 to Pemigatinib 13.5 mg QD
Participants received gemcitabine 1000 milligrams per square meter (mg/m\^2) plus cisplatin 25 mg/m\^2 intravenously on Days 1 and 8 every 3 weeks for up to 8 cycles (if 1 cycle was administered prior to randomization, the total of 8 cycles included that prior cycle as well). If disease progression occurred per RECIST v1.1 assessed by ICR, a transition to pemigatinib 13.5 mg QD was allowed.
|
|---|---|---|
|
Transition Period: ORR
|
38.1 percentage of participants
Interval 23.57 to 54.36
|
—
|
SECONDARY outcome
Timeframe: up to 1422 daysPopulation: ITT Population. Median survival time was estimated using the Kaplan-Meier method. The 95% CIs were calculated with the Brookmeyer and Crowley method (log-log transformation).
Overall survival was defined as the time from the date of randomization until death due to any cause.
Outcome measures
| Measure |
Pemigatinib 13.5 mg QD
n=83 Participants
Participants received oral pemigatinib 13.5 milligrams (mg) once daily (QD) continuous therapy in 3-week cycles. Treatment continued until disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) assessed by Independent Central Review (ICR), unacceptable toxicity, or another treatment discontinuation criterion was met.
|
Gemcitabine 1000 mg/m^2 Plus Cisplatin 25 mg/m^2 to Pemigatinib 13.5 mg QD
n=84 Participants
Participants received gemcitabine 1000 milligrams per square meter (mg/m\^2) plus cisplatin 25 mg/m\^2 intravenously on Days 1 and 8 every 3 weeks for up to 8 cycles (if 1 cycle was administered prior to randomization, the total of 8 cycles included that prior cycle as well). If disease progression occurred per RECIST v1.1 assessed by ICR, a transition to pemigatinib 13.5 mg QD was allowed.
|
|---|---|---|
|
Randomized Treatment Period: Overall Survival
|
24.38 months
Interval 18.63 to 35.91
|
25.00 months
Interval 18.66 to 34.2
|
SECONDARY outcome
Timeframe: up to 1422 daysPopulation: ITT Population. The number of participants analyzed for the Kaplan-Meier estimate at each time point refers to the total number of participants in the analysis set.
Overall survival was defined as the time from the date of randomization until death due to any cause. Kaplan-Meier estimates indicate the percent probability of a participant being alive at the indicated time after treatment start.
Outcome measures
| Measure |
Pemigatinib 13.5 mg QD
n=83 Participants
Participants received oral pemigatinib 13.5 milligrams (mg) once daily (QD) continuous therapy in 3-week cycles. Treatment continued until disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) assessed by Independent Central Review (ICR), unacceptable toxicity, or another treatment discontinuation criterion was met.
|
Gemcitabine 1000 mg/m^2 Plus Cisplatin 25 mg/m^2 to Pemigatinib 13.5 mg QD
n=84 Participants
Participants received gemcitabine 1000 milligrams per square meter (mg/m\^2) plus cisplatin 25 mg/m\^2 intravenously on Days 1 and 8 every 3 weeks for up to 8 cycles (if 1 cycle was administered prior to randomization, the total of 8 cycles included that prior cycle as well). If disease progression occurred per RECIST v1.1 assessed by ICR, a transition to pemigatinib 13.5 mg QD was allowed.
|
|---|---|---|
|
Randomized Treatment Period: Kaplan-Meier Estimates of Overall Survival of the Indicated Lengths of Time
3 months
|
95.2 percent probability
Interval 87.7 to 98.2
|
100.0 percent probability
Interval 100.0 to 100.0
|
|
Randomized Treatment Period: Kaplan-Meier Estimates of Overall Survival of the Indicated Lengths of Time
6 months
|
89.1 percent probability
Interval 80.1 to 94.2
|
97.2 percent probability
Interval 89.4 to 99.3
|
|
Randomized Treatment Period: Kaplan-Meier Estimates of Overall Survival of the Indicated Lengths of Time
9 months
|
81.7 percent probability
Interval 71.4 to 88.5
|
91.7 percent probability
Interval 82.4 to 96.2
|
|
Randomized Treatment Period: Kaplan-Meier Estimates of Overall Survival of the Indicated Lengths of Time
12 months
|
74.2 percent probability
Interval 63.3 to 82.4
|
84.7 percent probability
Interval 74.1 to 91.2
|
|
Randomized Treatment Period: Kaplan-Meier Estimates of Overall Survival of the Indicated Lengths of Time
24 months
|
51.0 percent probability
Interval 38.9 to 61.8
|
55.8 percent probability
Interval 43.0 to 66.7
|
|
Randomized Treatment Period: Kaplan-Meier Estimates of Overall Survival of the Indicated Lengths of Time
36 months
|
36.6 percent probability
Interval 24.9 to 48.3
|
34.1 percent probability
Interval 22.0 to 46.5
|
SECONDARY outcome
Timeframe: up to 1422 daysPopulation: ITT Population. Median survival time was estimated using the Kaplan-Meier method. The 95% CIs were calculated with the Brookmeyer and Crowley method (log-log transformation). Only participants with a CR or PR confirmed by an ICR were analyzed.
DOR was defined as the time from the date of the first assessment of CR or PR until the date of the first disease progression by an ICR per RECIST v1.1 or death, whichever occurred first. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.
Outcome measures
| Measure |
Pemigatinib 13.5 mg QD
n=39 Participants
Participants received oral pemigatinib 13.5 milligrams (mg) once daily (QD) continuous therapy in 3-week cycles. Treatment continued until disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) assessed by Independent Central Review (ICR), unacceptable toxicity, or another treatment discontinuation criterion was met.
|
Gemcitabine 1000 mg/m^2 Plus Cisplatin 25 mg/m^2 to Pemigatinib 13.5 mg QD
n=13 Participants
Participants received gemcitabine 1000 milligrams per square meter (mg/m\^2) plus cisplatin 25 mg/m\^2 intravenously on Days 1 and 8 every 3 weeks for up to 8 cycles (if 1 cycle was administered prior to randomization, the total of 8 cycles included that prior cycle as well). If disease progression occurred per RECIST v1.1 assessed by ICR, a transition to pemigatinib 13.5 mg QD was allowed.
|
|---|---|---|
|
Randomized Treatment Period: Duration of Response (DOR)
|
14.19 months
Interval 8.74 to 24.74
|
6.31 months
Interval 4.3 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
|
SECONDARY outcome
Timeframe: up to 1422 daysPopulation: ITT Population. The number of participants analyzed for the Kaplan-Meier estimate at each time point refers to the total number of participants in the analysis set.
DOR was defined as the time from the date of the first assessment of CR or PR until the date of the first disease progression by an ICR per RECIST v1.1 or death, whichever occurred first. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. Kaplan-Meier estimates indicate the percent probability of a participant still having a CR or PR at the indicated time after treatment start.
Outcome measures
| Measure |
Pemigatinib 13.5 mg QD
n=39 Participants
Participants received oral pemigatinib 13.5 milligrams (mg) once daily (QD) continuous therapy in 3-week cycles. Treatment continued until disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) assessed by Independent Central Review (ICR), unacceptable toxicity, or another treatment discontinuation criterion was met.
|
Gemcitabine 1000 mg/m^2 Plus Cisplatin 25 mg/m^2 to Pemigatinib 13.5 mg QD
n=13 Participants
Participants received gemcitabine 1000 milligrams per square meter (mg/m\^2) plus cisplatin 25 mg/m\^2 intravenously on Days 1 and 8 every 3 weeks for up to 8 cycles (if 1 cycle was administered prior to randomization, the total of 8 cycles included that prior cycle as well). If disease progression occurred per RECIST v1.1 assessed by ICR, a transition to pemigatinib 13.5 mg QD was allowed.
|
|---|---|---|
|
Randomized Treatment Period: Kaplan-Meier Estimates of DOR of the Indicated Lengths of Time
3 months
|
100.0 percent probability
Interval 100.0 to 100.0
|
100.0 percent probability
Interval 100.0 to 100.0
|
|
Randomized Treatment Period: Kaplan-Meier Estimates of DOR of the Indicated Lengths of Time
6 months
|
80.1 percent probability
Interval 62.8 to 90.0
|
55.0 percent probability
Interval 23.2 to 78.3
|
|
Randomized Treatment Period: Kaplan-Meier Estimates of DOR of the Indicated Lengths of Time
9 months
|
66.3 percent probability
Interval 47.1 to 79.9
|
45.8 percent probability
Interval 16.9 to 71.0
|
|
Randomized Treatment Period: Kaplan-Meier Estimates of DOR of the Indicated Lengths of Time
12 months
|
50.4 percent probability
Interval 31.0 to 67.0
|
34.4 percent probability
Interval 9.2 to 61.9
|
|
Randomized Treatment Period: Kaplan-Meier Estimates of DOR of the Indicated Lengths of Time
24 months
|
33.0 percent probability
Interval 14.0 to 53.6
|
NA percent probability
The upper and lower limits of the confidence interval were not estimable because no participants were still being followed without disease progression or had died.
|
|
Randomized Treatment Period: Kaplan-Meier Estimates of DOR of the Indicated Lengths of Time
36 months
|
24.8 percent probability
Interval 7.7 to 46.8
|
NA percent probability
The upper and lower limits of the confidence interval were not estimable because no participants were still being followed without disease progression or had died.
|
SECONDARY outcome
Timeframe: up to 1496 daysPopulation: Crossover Evaluable Population. Median survival time was estimated using the Kaplan-Meier method. The 95% CIs were calculated with the Brookmeyer and Crowley method (log-log transformation).
DOR was defined as the time from the date of the first assessment of CR or PR until the date of the first disease progression by an ICR per RECIST v1.1 or death, whichever occurred first. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.
Outcome measures
| Measure |
Pemigatinib 13.5 mg QD
n=16 Participants
Participants received oral pemigatinib 13.5 milligrams (mg) once daily (QD) continuous therapy in 3-week cycles. Treatment continued until disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) assessed by Independent Central Review (ICR), unacceptable toxicity, or another treatment discontinuation criterion was met.
|
Gemcitabine 1000 mg/m^2 Plus Cisplatin 25 mg/m^2 to Pemigatinib 13.5 mg QD
Participants received gemcitabine 1000 milligrams per square meter (mg/m\^2) plus cisplatin 25 mg/m\^2 intravenously on Days 1 and 8 every 3 weeks for up to 8 cycles (if 1 cycle was administered prior to randomization, the total of 8 cycles included that prior cycle as well). If disease progression occurred per RECIST v1.1 assessed by ICR, a transition to pemigatinib 13.5 mg QD was allowed.
|
|---|---|---|
|
Transition Period: DOR
|
6.21 months
Interval 4.17 to 12.45
|
—
|
SECONDARY outcome
Timeframe: up to 1496 daysPopulation: Crossover Evaluable Population. The number of participants analyzed for the Kaplan-Meier estimate at each time point refers to the total number of participants in the analysis set.
DOR was defined as the time from the date of the first assessment of CR or PR until the date of the first disease progression by an ICR per RECIST v1.1 or death, whichever occurred first. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. Kaplan-Meier estimates indicate the percent probability of a participant still having a CR or PR at the indicated time after treatment start.
Outcome measures
| Measure |
Pemigatinib 13.5 mg QD
n=16 Participants
Participants received oral pemigatinib 13.5 milligrams (mg) once daily (QD) continuous therapy in 3-week cycles. Treatment continued until disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) assessed by Independent Central Review (ICR), unacceptable toxicity, or another treatment discontinuation criterion was met.
|
Gemcitabine 1000 mg/m^2 Plus Cisplatin 25 mg/m^2 to Pemigatinib 13.5 mg QD
Participants received gemcitabine 1000 milligrams per square meter (mg/m\^2) plus cisplatin 25 mg/m\^2 intravenously on Days 1 and 8 every 3 weeks for up to 8 cycles (if 1 cycle was administered prior to randomization, the total of 8 cycles included that prior cycle as well). If disease progression occurred per RECIST v1.1 assessed by ICR, a transition to pemigatinib 13.5 mg QD was allowed.
|
|---|---|---|
|
Transition Period: Kaplan-Meier Estimates of DOR of the Indicated Lengths of Time
3 months
|
100.0 percent probability
Interval 100.0 to 100.0
|
—
|
|
Transition Period: Kaplan-Meier Estimates of DOR of the Indicated Lengths of Time
6 months
|
61.4 percent probability
Interval 33.3 to 80.5
|
—
|
|
Transition Period: Kaplan-Meier Estimates of DOR of the Indicated Lengths of Time
9 months
|
29.8 percent probability
Interval 8.6 to 55.0
|
—
|
|
Transition Period: Kaplan-Meier Estimates of DOR of the Indicated Lengths of Time
12 months
|
29.8 percent probability
Interval 8.6 to 55.0
|
—
|
|
Transition Period: Kaplan-Meier Estimates of DOR of the Indicated Lengths of Time
24 months
|
0.0 percent probability
The upper and lower limits of the confidence interval were not estimable because no participants were still being followed without disease progression or had died.
|
—
|
|
Transition Period: Kaplan-Meier Estimates of DOR of the Indicated Lengths of Time
36 months
|
0.0 percent probability
The upper and lower limits of the confidence interval were not estimable because no participants were still being followed without disease progression or had died.
|
—
|
SECONDARY outcome
Timeframe: up to 1422 daysPopulation: ITT Population. The confidence interval was calculated based on the exact method for binomial distribution.
DCR was defined as the percentage of participants who achieved a best overall response of CR, PR, or SD per RECIST v1.1 as assessed by an ICR. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
Outcome measures
| Measure |
Pemigatinib 13.5 mg QD
n=83 Participants
Participants received oral pemigatinib 13.5 milligrams (mg) once daily (QD) continuous therapy in 3-week cycles. Treatment continued until disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) assessed by Independent Central Review (ICR), unacceptable toxicity, or another treatment discontinuation criterion was met.
|
Gemcitabine 1000 mg/m^2 Plus Cisplatin 25 mg/m^2 to Pemigatinib 13.5 mg QD
n=84 Participants
Participants received gemcitabine 1000 milligrams per square meter (mg/m\^2) plus cisplatin 25 mg/m\^2 intravenously on Days 1 and 8 every 3 weeks for up to 8 cycles (if 1 cycle was administered prior to randomization, the total of 8 cycles included that prior cycle as well). If disease progression occurred per RECIST v1.1 assessed by ICR, a transition to pemigatinib 13.5 mg QD was allowed.
|
|---|---|---|
|
Randomized Treatment Period: Disease Control Rate (DCR)
|
89.2 percentage of participants
Interval 80.41 to 94.92
|
67.9 percentage of participants
Interval 56.78 to 77.64
|
SECONDARY outcome
Timeframe: up to 1496 daysPopulation: Crossover Evaluable Population. The confidence interval was calculated based on the exact method for binomial distribution.
DCR was defined as the percentage of participants who achieved a best overall response of CR, PR, or SD per RECIST v1.1 as assessed by an ICR. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
Outcome measures
| Measure |
Pemigatinib 13.5 mg QD
n=42 Participants
Participants received oral pemigatinib 13.5 milligrams (mg) once daily (QD) continuous therapy in 3-week cycles. Treatment continued until disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) assessed by Independent Central Review (ICR), unacceptable toxicity, or another treatment discontinuation criterion was met.
|
Gemcitabine 1000 mg/m^2 Plus Cisplatin 25 mg/m^2 to Pemigatinib 13.5 mg QD
Participants received gemcitabine 1000 milligrams per square meter (mg/m\^2) plus cisplatin 25 mg/m\^2 intravenously on Days 1 and 8 every 3 weeks for up to 8 cycles (if 1 cycle was administered prior to randomization, the total of 8 cycles included that prior cycle as well). If disease progression occurred per RECIST v1.1 assessed by ICR, a transition to pemigatinib 13.5 mg QD was allowed.
|
|---|---|---|
|
Transition Period: DCR
|
83.3 percentage of participants
Interval 68.64 to 93.03
|
—
|
SECONDARY outcome
Timeframe: up to 1457 daysPopulation: Safety Population: all randomized participants who received at least 1 dose of study drug (pemigatinib, gemcitabine, or cisplatin). Treatment groups were determined according to the actual treatment the participant received regardless of assigned study drug treatment.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until 30 days after the last dose of study drug for participants who did not transition to pemigatinib. For participants who transitioned to pemigatinib, the end date was 30 days after the last dose date of gemcitabine plus cisplatin or the day before the first dose of pemigatinib after transition, whichever occurred first.
Outcome measures
| Measure |
Pemigatinib 13.5 mg QD
n=83 Participants
Participants received oral pemigatinib 13.5 milligrams (mg) once daily (QD) continuous therapy in 3-week cycles. Treatment continued until disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) assessed by Independent Central Review (ICR), unacceptable toxicity, or another treatment discontinuation criterion was met.
|
Gemcitabine 1000 mg/m^2 Plus Cisplatin 25 mg/m^2 to Pemigatinib 13.5 mg QD
n=73 Participants
Participants received gemcitabine 1000 milligrams per square meter (mg/m\^2) plus cisplatin 25 mg/m\^2 intravenously on Days 1 and 8 every 3 weeks for up to 8 cycles (if 1 cycle was administered prior to randomization, the total of 8 cycles included that prior cycle as well). If disease progression occurred per RECIST v1.1 assessed by ICR, a transition to pemigatinib 13.5 mg QD was allowed.
|
|---|---|---|
|
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
|
83 Participants
|
73 Participants
|
SECONDARY outcome
Timeframe: up to 1457 daysPopulation: Safety Population
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until 30 days after the last dose of study drug for participants who did not transition to pemigatinib. For participants who transitioned to pemigatinib, the end date was 30 days after the last dose date of gemcitabine plus cisplatin or the day before the first dose of pemigatinib after transition, whichever occurred first.
Outcome measures
| Measure |
Pemigatinib 13.5 mg QD
n=83 Participants
Participants received oral pemigatinib 13.5 milligrams (mg) once daily (QD) continuous therapy in 3-week cycles. Treatment continued until disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) assessed by Independent Central Review (ICR), unacceptable toxicity, or another treatment discontinuation criterion was met.
|
Gemcitabine 1000 mg/m^2 Plus Cisplatin 25 mg/m^2 to Pemigatinib 13.5 mg QD
n=73 Participants
Participants received gemcitabine 1000 milligrams per square meter (mg/m\^2) plus cisplatin 25 mg/m\^2 intravenously on Days 1 and 8 every 3 weeks for up to 8 cycles (if 1 cycle was administered prior to randomization, the total of 8 cycles included that prior cycle as well). If disease progression occurred per RECIST v1.1 assessed by ICR, a transition to pemigatinib 13.5 mg QD was allowed.
|
|---|---|---|
|
Number of Participants With Any Treatment-related TEAE
|
80 Participants
|
70 Participants
|
SECONDARY outcome
Timeframe: up to 1531 daysPopulation: Crossover Evaluable Population
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE for the Crossover Evaluable Population was any AE either reported for the first time or for a worsened pre-existing event after the first dose of pemigatinib after switch and until 30 days after the last dose of pemigatinib.
Outcome measures
| Measure |
Pemigatinib 13.5 mg QD
n=42 Participants
Participants received oral pemigatinib 13.5 milligrams (mg) once daily (QD) continuous therapy in 3-week cycles. Treatment continued until disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) assessed by Independent Central Review (ICR), unacceptable toxicity, or another treatment discontinuation criterion was met.
|
Gemcitabine 1000 mg/m^2 Plus Cisplatin 25 mg/m^2 to Pemigatinib 13.5 mg QD
Participants received gemcitabine 1000 milligrams per square meter (mg/m\^2) plus cisplatin 25 mg/m\^2 intravenously on Days 1 and 8 every 3 weeks for up to 8 cycles (if 1 cycle was administered prior to randomization, the total of 8 cycles included that prior cycle as well). If disease progression occurred per RECIST v1.1 assessed by ICR, a transition to pemigatinib 13.5 mg QD was allowed.
|
|---|---|---|
|
Transition Period: Number of Participants With Any TEAE
|
42 Participants
|
—
|
SECONDARY outcome
Timeframe: up to 1531 daysPopulation: Crossover Evaluable Population
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE for the Crossover Evaluable Population was any AE either reported for the first time or for a worsened pre-existing event after the first dose of pemigatinib after switch and until 30 days after the last dose of pemigatinib.
Outcome measures
| Measure |
Pemigatinib 13.5 mg QD
n=42 Participants
Participants received oral pemigatinib 13.5 milligrams (mg) once daily (QD) continuous therapy in 3-week cycles. Treatment continued until disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) assessed by Independent Central Review (ICR), unacceptable toxicity, or another treatment discontinuation criterion was met.
|
Gemcitabine 1000 mg/m^2 Plus Cisplatin 25 mg/m^2 to Pemigatinib 13.5 mg QD
Participants received gemcitabine 1000 milligrams per square meter (mg/m\^2) plus cisplatin 25 mg/m\^2 intravenously on Days 1 and 8 every 3 weeks for up to 8 cycles (if 1 cycle was administered prior to randomization, the total of 8 cycles included that prior cycle as well). If disease progression occurred per RECIST v1.1 assessed by ICR, a transition to pemigatinib 13.5 mg QD was allowed.
|
|---|---|---|
|
Transition Period: Number of Participants With Any Treatment-related TEAE
|
41 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline; up to 1422 daysPopulation: ITT Population. Only participants with available data were analyzed.
The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures. These include 5 functional scales (physical functioning, role, cognitive functioning, emotional functioning, and social functioning), 3 symptom scales (fatigue, pain, and nausea/vomiting), a global health status scale, and 6 single items (constipation, diarrhea, sleep, dyspnea, appetite, financial). All scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Therefore, a high score for a functional scale represents a high/healthy level of functioning and a high score for the global health status/QoL represents a high QoL. A high score for a symptom scale/item represents a high level of symptomatology/problems. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Outcome measures
| Measure |
Pemigatinib 13.5 mg QD
n=83 Participants
Participants received oral pemigatinib 13.5 milligrams (mg) once daily (QD) continuous therapy in 3-week cycles. Treatment continued until disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) assessed by Independent Central Review (ICR), unacceptable toxicity, or another treatment discontinuation criterion was met.
|
Gemcitabine 1000 mg/m^2 Plus Cisplatin 25 mg/m^2 to Pemigatinib 13.5 mg QD
n=84 Participants
Participants received gemcitabine 1000 milligrams per square meter (mg/m\^2) plus cisplatin 25 mg/m\^2 intravenously on Days 1 and 8 every 3 weeks for up to 8 cycles (if 1 cycle was administered prior to randomization, the total of 8 cycles included that prior cycle as well). If disease progression occurred per RECIST v1.1 assessed by ICR, a transition to pemigatinib 13.5 mg QD was allowed.
|
|---|---|---|
|
Randomized Treatment Period: Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-30) Scores at Early Termination
Baseline, Appetite loss
|
17.1 scores on a scale
Standard Deviation 27.56
|
22.4 scores on a scale
Standard Deviation 31.46
|
|
Randomized Treatment Period: Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-30) Scores at Early Termination
CFB at Early Termination, Appetite loss
|
10.2 scores on a scale
Standard Deviation 26.71
|
-3.7 scores on a scale
Standard Deviation 32.64
|
|
Randomized Treatment Period: Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-30) Scores at Early Termination
Baseline, Constipation
|
12.9 scores on a scale
Standard Deviation 18.75
|
14.9 scores on a scale
Standard Deviation 23.42
|
|
Randomized Treatment Period: Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-30) Scores at Early Termination
CFB at Early Termination, Constipation
|
11.8 scores on a scale
Standard Deviation 27.06
|
0.9 scores on a scale
Standard Deviation 30.33
|
|
Randomized Treatment Period: Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-30) Scores at Early Termination
Baseline, Cognitive functioning
|
86.4 scores on a scale
Standard Deviation 15.16
|
91.2 scores on a scale
Standard Deviation 13.15
|
|
Randomized Treatment Period: Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-30) Scores at Early Termination
CFB at Early Termination, Cognitive functioning
|
-5.4 scores on a scale
Standard Deviation 18.05
|
-1.9 scores on a scale
Standard Deviation 23.14
|
|
Randomized Treatment Period: Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-30) Scores at Early Termination
Baseline, Diarrhea
|
11.1 scores on a scale
Standard Deviation 22.36
|
6.5 scores on a scale
Standard Deviation 15.61
|
|
Randomized Treatment Period: Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-30) Scores at Early Termination
CFB at Early Termination, Diarrhea
|
0.5 scores on a scale
Standard Deviation 20.46
|
0.9 scores on a scale
Standard Deviation 12.56
|
|
Randomized Treatment Period: Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-30) Scores at Early Termination
Baseline, Dyspnea
|
16.9 scores on a scale
Standard Deviation 24.22
|
14.9 scores on a scale
Standard Deviation 21.15
|
|
Randomized Treatment Period: Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-30) Scores at Early Termination
CFB at Early Termination, Dyspnea
|
2.2 scores on a scale
Standard Deviation 24.05
|
8.3 scores on a scale
Standard Deviation 26.87
|
|
Randomized Treatment Period: Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-30) Scores at Early Termination
Baseline, Emotional functioning
|
75.9 scores on a scale
Standard Deviation 19.21
|
78.2 scores on a scale
Standard Deviation 20.15
|
|
Randomized Treatment Period: Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-30) Scores at Early Termination
CFB at Early Termination, Emotional functioning
|
-5.6 scores on a scale
Standard Deviation 20.90
|
-9.3 scores on a scale
Standard Deviation 19.60
|
|
Randomized Treatment Period: Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-30) Scores at Early Termination
Baseline, Fatigue
|
31.0 scores on a scale
Standard Deviation 25.38
|
26.2 scores on a scale
Standard Deviation 22.53
|
|
Randomized Treatment Period: Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-30) Scores at Early Termination
CFB at Early Termination, Fatigue
|
6.8 scores on a scale
Standard Deviation 20.94
|
10.6 scores on a scale
Standard Deviation 22.16
|
|
Randomized Treatment Period: Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-30) Scores at Early Termination
Baseline, Financial difficulties
|
14.0 scores on a scale
Standard Deviation 24.64
|
20.4 scores on a scale
Standard Deviation 31.76
|
|
Randomized Treatment Period: Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-30) Scores at Early Termination
CFB at Early Termination, Financial difficulties
|
8.1 scores on a scale
Standard Deviation 29.37
|
7.4 scores on a scale
Standard Deviation 26.56
|
|
Randomized Treatment Period: Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-30) Scores at Early Termination
Baseline, Global health status/QoL
|
66.7 scores on a scale
Standard Deviation 22.82
|
67.5 scores on a scale
Standard Deviation 20.00
|
|
Randomized Treatment Period: Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-30) Scores at Early Termination
CFB at Early Termination, Global health status/QoL
|
-8.3 scores on a scale
Standard Deviation 20.36
|
-6.0 scores on a scale
Standard Deviation 22.85
|
|
Randomized Treatment Period: Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-30) Scores at Early Termination
Baseline, Insomnia
|
30.5 scores on a scale
Standard Deviation 31.27
|
24.9 scores on a scale
Standard Deviation 28.63
|
|
Randomized Treatment Period: Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-30) Scores at Early Termination
CFB at Early Termination, Insomnia
|
-6.5 scores on a scale
Standard Deviation 29.47
|
-3.7 scores on a scale
Standard Deviation 23.61
|
|
Randomized Treatment Period: Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-30) Scores at Early Termination
Baseline, Nausea and vomiting
|
8.6 scores on a scale
Standard Deviation 16.27
|
11.1 scores on a scale
Standard Deviation 21.94
|
|
Randomized Treatment Period: Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-30) Scores at Early Termination
CFB at Early Termination, Nausea and vomiting
|
-1.9 scores on a scale
Standard Deviation 18.13
|
1.4 scores on a scale
Standard Deviation 21.91
|
|
Randomized Treatment Period: Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-30) Scores at Early Termination
Baseline, Pain
|
24.6 scores on a scale
Standard Deviation 28.56
|
20.1 scores on a scale
Standard Deviation 23.31
|
|
Randomized Treatment Period: Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-30) Scores at Early Termination
CFB at Early Termination, Pain
|
6.6 scores on a scale
Standard Deviation 29.07
|
2.3 scores on a scale
Standard Deviation 22.24
|
|
Randomized Treatment Period: Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-30) Scores at Early Termination
Baseline, Physical functioning
|
82.3 scores on a scale
Standard Deviation 21.45
|
82.7 scores on a scale
Standard Deviation 19.21
|
|
Randomized Treatment Period: Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-30) Scores at Early Termination
CFB at Early Termination, Physical functioning
|
-11.6 scores on a scale
Standard Deviation 20.36
|
-5.6 scores on a scale
Standard Deviation 22.79
|
|
Randomized Treatment Period: Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-30) Scores at Early Termination
Baseline, Role functioning
|
76.7 scores on a scale
Standard Deviation 31.14
|
79.1 scores on a scale
Standard Deviation 24.51
|
|
Randomized Treatment Period: Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-30) Scores at Early Termination
CFB at Early Termination, Role functioning
|
-18.0 scores on a scale
Standard Deviation 31.26
|
-13.0 scores on a scale
Standard Deviation 26.16
|
|
Randomized Treatment Period: Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-30) Scores at Early Termination
Baseline, Social functioning
|
77.4 scores on a scale
Standard Deviation 26.00
|
77.4 scores on a scale
Standard Deviation 24.91
|
|
Randomized Treatment Period: Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-30) Scores at Early Termination
CFB at Early termination, Social functioning
|
-12.4 scores on a scale
Standard Deviation 27.65
|
-11.1 scores on a scale
Standard Deviation 21.82
|
SECONDARY outcome
Timeframe: Baseline; up to 1422 daysPopulation: ITT Population. Only participants with available data were analyzed.
The EORTC QLQ-BIL21 assessed QoL across 8 scales: eating, jaundice, tiredness, pain, anxiety, treatment side effects, drains, and weight loss. The raw score of each scale is the mean of the item values that contribute to the scale, and the standardized score is a linear transformation of the raw score so that the range is from 0 to 100. A high score for a symptom scale represents a high level of symptomatology/problems. The BIL21 questionnaire was only be administered to participants for whom the questionnaire is validated in that language. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Outcome measures
| Measure |
Pemigatinib 13.5 mg QD
n=83 Participants
Participants received oral pemigatinib 13.5 milligrams (mg) once daily (QD) continuous therapy in 3-week cycles. Treatment continued until disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) assessed by Independent Central Review (ICR), unacceptable toxicity, or another treatment discontinuation criterion was met.
|
Gemcitabine 1000 mg/m^2 Plus Cisplatin 25 mg/m^2 to Pemigatinib 13.5 mg QD
n=84 Participants
Participants received gemcitabine 1000 milligrams per square meter (mg/m\^2) plus cisplatin 25 mg/m\^2 intravenously on Days 1 and 8 every 3 weeks for up to 8 cycles (if 1 cycle was administered prior to randomization, the total of 8 cycles included that prior cycle as well). If disease progression occurred per RECIST v1.1 assessed by ICR, a transition to pemigatinib 13.5 mg QD was allowed.
|
|---|---|---|
|
Randomized Treatment Period: Change From Baseline (CFB) in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Including 21 Questions Specific to the Biliary System (EORTC QLQ-BIL21) at Early Termination
Baseline, Anxiety
|
35.9 scores on a scale
Standard Deviation 24.78
|
36.1 scores on a scale
Standard Deviation 25.83
|
|
Randomized Treatment Period: Change From Baseline (CFB) in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Including 21 Questions Specific to the Biliary System (EORTC QLQ-BIL21) at Early Termination
CFB at Early Termination, Anxiety
|
5.7 scores on a scale
Standard Deviation 24.43
|
0.8 scores on a scale
Standard Deviation 18.50
|
|
Randomized Treatment Period: Change From Baseline (CFB) in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Including 21 Questions Specific to the Biliary System (EORTC QLQ-BIL21) at Early Termination
Baseline, Drains
|
2.3 scores on a scale
Standard Deviation 10.14
|
2.9 scores on a scale
Standard Deviation 12.92
|
|
Randomized Treatment Period: Change From Baseline (CFB) in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Including 21 Questions Specific to the Biliary System (EORTC QLQ-BIL21) at Early Termination
CFB at Early Termination, Drains
|
3.0 scores on a scale
Standard Deviation 17.15
|
7.8 scores on a scale
Standard Deviation 27.24
|
|
Randomized Treatment Period: Change From Baseline (CFB) in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Including 21 Questions Specific to the Biliary System (EORTC QLQ-BIL21) at Early Termination
Baseline, Eating
|
14.9 scores on a scale
Standard Deviation 17.34
|
17.5 scores on a scale
Standard Deviation 19.44
|
|
Randomized Treatment Period: Change From Baseline (CFB) in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Including 21 Questions Specific to the Biliary System (EORTC QLQ-BIL21) at Early Termination
CFB at Early Termination, Eating
|
12.2 scores on a scale
Standard Deviation 19.68
|
3.9 scores on a scale
Standard Deviation 21.22
|
|
Randomized Treatment Period: Change From Baseline (CFB) in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Including 21 Questions Specific to the Biliary System (EORTC QLQ-BIL21) at Early Termination
Baseline, Jaundice
|
5.6 scores on a scale
Standard Deviation 10.40
|
5.6 scores on a scale
Standard Deviation 10.61
|
|
Randomized Treatment Period: Change From Baseline (CFB) in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Including 21 Questions Specific to the Biliary System (EORTC QLQ-BIL21) at Early Termination
CFB at Early Termination, Jaundice
|
-1.7 scores on a scale
Standard Deviation 9.99
|
1.5 scores on a scale
Standard Deviation 10.67
|
|
Randomized Treatment Period: Change From Baseline (CFB) in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Including 21 Questions Specific to the Biliary System (EORTC QLQ-BIL21) at Early Termination
Baseline, Pain
|
22.5 scores on a scale
Standard Deviation 19.97
|
18.8 scores on a scale
Standard Deviation 18.62
|
|
Randomized Treatment Period: Change From Baseline (CFB) in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Including 21 Questions Specific to the Biliary System (EORTC QLQ-BIL21) at Early Termination
CFB at Early Termination, Pain
|
-7.6 scores on a scale
Standard Deviation 20.31
|
5.9 scores on a scale
Standard Deviation 15.30
|
|
Randomized Treatment Period: Change From Baseline (CFB) in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Including 21 Questions Specific to the Biliary System (EORTC QLQ-BIL21) at Early Termination
Baseline, Treatment side effects
|
14.4 scores on a scale
Standard Deviation 25.33
|
13.0 scores on a scale
Standard Deviation 25.53
|
|
Randomized Treatment Period: Change From Baseline (CFB) in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Including 21 Questions Specific to the Biliary System (EORTC QLQ-BIL21) at Early Termination
CFB at Early Termination, Treatment side effects
|
30.5 scores on a scale
Standard Deviation 36.56
|
11.5 scores on a scale
Standard Deviation 30.06
|
|
Randomized Treatment Period: Change From Baseline (CFB) in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Including 21 Questions Specific to the Biliary System (EORTC QLQ-BIL21) at Early Termination
Baseline, Tiredness
|
34.8 scores on a scale
Standard Deviation 31.09
|
33.7 scores on a scale
Standard Deviation 32.32
|
|
Randomized Treatment Period: Change From Baseline (CFB) in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Including 21 Questions Specific to the Biliary System (EORTC QLQ-BIL21) at Early Termination
CFB at Early Termination, Tiredness
|
6.9 scores on a scale
Standard Deviation 26.99
|
4.0 scores on a scale
Standard Deviation 28.87
|
|
Randomized Treatment Period: Change From Baseline (CFB) in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Including 21 Questions Specific to the Biliary System (EORTC QLQ-BIL21) at Early Termination
Baseline, Weight loss
|
18.7 scores on a scale
Standard Deviation 25.26
|
21.0 scores on a scale
Standard Deviation 27.81
|
|
Randomized Treatment Period: Change From Baseline (CFB) in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Including 21 Questions Specific to the Biliary System (EORTC QLQ-BIL21) at Early Termination
CFB at Early Termination, Weight loss
|
2.9 scores on a scale
Standard Deviation 22.76
|
-9.8 scores on a scale
Standard Deviation 33.36
|
SECONDARY outcome
Timeframe: Baseline; up to 1422 daysPopulation: ITT Population. Only participants with available data were analyzed.
The EQ-5D (3L) is the descriptive system that comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems.
Outcome measures
| Measure |
Pemigatinib 13.5 mg QD
n=83 Participants
Participants received oral pemigatinib 13.5 milligrams (mg) once daily (QD) continuous therapy in 3-week cycles. Treatment continued until disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) assessed by Independent Central Review (ICR), unacceptable toxicity, or another treatment discontinuation criterion was met.
|
Gemcitabine 1000 mg/m^2 Plus Cisplatin 25 mg/m^2 to Pemigatinib 13.5 mg QD
n=84 Participants
Participants received gemcitabine 1000 milligrams per square meter (mg/m\^2) plus cisplatin 25 mg/m\^2 intravenously on Days 1 and 8 every 3 weeks for up to 8 cycles (if 1 cycle was administered prior to randomization, the total of 8 cycles included that prior cycle as well). If disease progression occurred per RECIST v1.1 assessed by ICR, a transition to pemigatinib 13.5 mg QD was allowed.
|
|---|---|---|
|
Randomized Treatment Period: Number of Participants With the Indicated Responses on the European Quality of Life 5 Dimensions (3 Levels) Questionnaire (EQ-5D [3L])
Baseline, Usual Activities; extreme problems
|
46 Participants
|
38 Participants
|
|
Randomized Treatment Period: Number of Participants With the Indicated Responses on the European Quality of Life 5 Dimensions (3 Levels) Questionnaire (EQ-5D [3L])
Baseline, Anxiety/Depression; some problems
|
60 Participants
|
52 Participants
|
|
Randomized Treatment Period: Number of Participants With the Indicated Responses on the European Quality of Life 5 Dimensions (3 Levels) Questionnaire (EQ-5D [3L])
Baseline, Mobility; extreme problems
|
5 Participants
|
3 Participants
|
|
Randomized Treatment Period: Number of Participants With the Indicated Responses on the European Quality of Life 5 Dimensions (3 Levels) Questionnaire (EQ-5D [3L])
Baseline, Anxiety/Depression; extreme problems
|
18 Participants
|
15 Participants
|
|
Randomized Treatment Period: Number of Participants With the Indicated Responses on the European Quality of Life 5 Dimensions (3 Levels) Questionnaire (EQ-5D [3L])
Early Termination, Anxiety/Depression; no problems
|
3 Participants
|
0 Participants
|
|
Randomized Treatment Period: Number of Participants With the Indicated Responses on the European Quality of Life 5 Dimensions (3 Levels) Questionnaire (EQ-5D [3L])
Early Termination, Anxiety/Depression; some problems
|
36 Participants
|
26 Participants
|
|
Randomized Treatment Period: Number of Participants With the Indicated Responses on the European Quality of Life 5 Dimensions (3 Levels) Questionnaire (EQ-5D [3L])
Early Termination, Anxiety/Depression; extreme problems
|
24 Participants
|
11 Participants
|
|
Randomized Treatment Period: Number of Participants With the Indicated Responses on the European Quality of Life 5 Dimensions (3 Levels) Questionnaire (EQ-5D [3L])
Baseline, Mobility; no problems
|
2 Participants
|
0 Participants
|
|
Randomized Treatment Period: Number of Participants With the Indicated Responses on the European Quality of Life 5 Dimensions (3 Levels) Questionnaire (EQ-5D [3L])
Baseline, Mobility; some problems
|
74 Participants
|
65 Participants
|
|
Randomized Treatment Period: Number of Participants With the Indicated Responses on the European Quality of Life 5 Dimensions (3 Levels) Questionnaire (EQ-5D [3L])
Baseline, Anxiety/Depression; no problems
|
2 Participants
|
1 Participants
|
|
Randomized Treatment Period: Number of Participants With the Indicated Responses on the European Quality of Life 5 Dimensions (3 Levels) Questionnaire (EQ-5D [3L])
Early Termination, Mobility; no problems
|
1 Participants
|
1 Participants
|
|
Randomized Treatment Period: Number of Participants With the Indicated Responses on the European Quality of Life 5 Dimensions (3 Levels) Questionnaire (EQ-5D [3L])
Early Termination, Mobility; some problems
|
47 Participants
|
33 Participants
|
|
Randomized Treatment Period: Number of Participants With the Indicated Responses on the European Quality of Life 5 Dimensions (3 Levels) Questionnaire (EQ-5D [3L])
Early Termination, Mobility; extreme problems
|
15 Participants
|
3 Participants
|
|
Randomized Treatment Period: Number of Participants With the Indicated Responses on the European Quality of Life 5 Dimensions (3 Levels) Questionnaire (EQ-5D [3L])
Baseline, Pain/Discomfort; no problems
|
5 Participants
|
3 Participants
|
|
Randomized Treatment Period: Number of Participants With the Indicated Responses on the European Quality of Life 5 Dimensions (3 Levels) Questionnaire (EQ-5D [3L])
Baseline, Pain/Discomfort; some problems
|
52 Participants
|
43 Participants
|
|
Randomized Treatment Period: Number of Participants With the Indicated Responses on the European Quality of Life 5 Dimensions (3 Levels) Questionnaire (EQ-5D [3L])
Baseline, Pain/Discomfort; extreme problems
|
23 Participants
|
22 Participants
|
|
Randomized Treatment Period: Number of Participants With the Indicated Responses on the European Quality of Life 5 Dimensions (3 Levels) Questionnaire (EQ-5D [3L])
Early Termination, Pain/Discomfort; no problems
|
6 Participants
|
3 Participants
|
|
Randomized Treatment Period: Number of Participants With the Indicated Responses on the European Quality of Life 5 Dimensions (3 Levels) Questionnaire (EQ-5D [3L])
Early Termination, Pain/Discomfort; some problems
|
28 Participants
|
22 Participants
|
|
Randomized Treatment Period: Number of Participants With the Indicated Responses on the European Quality of Life 5 Dimensions (3 Levels) Questionnaire (EQ-5D [3L])
Early Termination, Pain/Discomfort; extreme problems
|
28 Participants
|
12 Participants
|
|
Randomized Treatment Period: Number of Participants With the Indicated Responses on the European Quality of Life 5 Dimensions (3 Levels) Questionnaire (EQ-5D [3L])
Baseline, Self-care; no problems
|
4 Participants
|
3 Participants
|
|
Randomized Treatment Period: Number of Participants With the Indicated Responses on the European Quality of Life 5 Dimensions (3 Levels) Questionnaire (EQ-5D [3L])
Baseline, Self-care; some problems
|
41 Participants
|
36 Participants
|
|
Randomized Treatment Period: Number of Participants With the Indicated Responses on the European Quality of Life 5 Dimensions (3 Levels) Questionnaire (EQ-5D [3L])
Baseline, Self-care; extreme problems
|
35 Participants
|
28 Participants
|
|
Randomized Treatment Period: Number of Participants With the Indicated Responses on the European Quality of Life 5 Dimensions (3 Levels) Questionnaire (EQ-5D [3L])
Early Termination; Self-care; no problems
|
2 Participants
|
0 Participants
|
|
Randomized Treatment Period: Number of Participants With the Indicated Responses on the European Quality of Life 5 Dimensions (3 Levels) Questionnaire (EQ-5D [3L])
Early Termination; Self-care; some problems
|
42 Participants
|
14 Participants
|
|
Randomized Treatment Period: Number of Participants With the Indicated Responses on the European Quality of Life 5 Dimensions (3 Levels) Questionnaire (EQ-5D [3L])
Early Termination; Self-care; extreme problems
|
19 Participants
|
23 Participants
|
|
Randomized Treatment Period: Number of Participants With the Indicated Responses on the European Quality of Life 5 Dimensions (3 Levels) Questionnaire (EQ-5D [3L])
Baseline, Usual Activities; no problems
|
2 Participants
|
1 Participants
|
|
Randomized Treatment Period: Number of Participants With the Indicated Responses on the European Quality of Life 5 Dimensions (3 Levels) Questionnaire (EQ-5D [3L])
Baseline, Usual Activities; some problems
|
33 Participants
|
29 Participants
|
|
Randomized Treatment Period: Number of Participants With the Indicated Responses on the European Quality of Life 5 Dimensions (3 Levels) Questionnaire (EQ-5D [3L])
Early Termination, Usual Activities; no problems
|
3 Participants
|
2 Participants
|
|
Randomized Treatment Period: Number of Participants With the Indicated Responses on the European Quality of Life 5 Dimensions (3 Levels) Questionnaire (EQ-5D [3L])
Early Termination, Usual Activities; some problems
|
30 Participants
|
17 Participants
|
|
Randomized Treatment Period: Number of Participants With the Indicated Responses on the European Quality of Life 5 Dimensions (3 Levels) Questionnaire (EQ-5D [3L])
Early Termination, Usual Activities; extreme problems
|
30 Participants
|
18 Participants
|
Adverse Events
Randomized Period: Pemigatinib 13.5 mg QD
Serious events: 23 serious events
Other events: 83 other events
Deaths: 51 deaths
Randomized Period: Gemcitabine 1000 mg/m^2 Plus Cisplatin 25 mg/m^2
Serious events: 17 serious events
Other events: 72 other events
Deaths: 47 deaths
Transition Period: Pemigatinib 13.5 mg QD
Serious events: 9 serious events
Other events: 42 other events
Deaths: 27 deaths
Serious adverse events
| Measure |
Randomized Period: Pemigatinib 13.5 mg QD
n=83 participants at risk
Participants received oral pemigatinib 13.5 milligrams (mg) once daily (QD) continuous therapy in 3-week cycles. Treatment continued until disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) assessed by Independent Central Review (ICR), unacceptable toxicity, or another treatment discontinuation criterion was met.
|
Randomized Period: Gemcitabine 1000 mg/m^2 Plus Cisplatin 25 mg/m^2
n=73 participants at risk
Participants received gemcitabine 1000 milligrams per square meter (mg/m\^2) plus cisplatin 25 mg/m\^2 intravenously on Days 1 and 8 every 3 weeks for up to 8 cycles (if 1 cycle was administered prior to randomization, the total of 8 cycles included that prior cycle as well).
|
Transition Period: Pemigatinib 13.5 mg QD
n=42 participants at risk
Participants who received gemcitabine 1000 mg/m\^2 plus cisplatin 25 mg/m\^2 intravenously on Days 1 and 8 every 3 weeks for up to 8 cycles (if 1 cycle was administered prior to randomization, the total of 8 cycles included that prior cycle as well) transitioned to pemigatinib 13.5 mg QD after experiencing disease progression per RECIST v1.1 assessed by ICR.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
1/83 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
2.4%
1/42 • Number of events 2 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.2%
1/83 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/83 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
1.4%
1/73 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
2.4%
1/42 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/83 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
1.4%
1/73 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
2.4%
1/42 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
General disorders
Asthenia
|
1.2%
1/83 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Nervous system disorders
Ataxia
|
1.2%
1/83 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/83 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
1.4%
1/73 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
2.4%
1/42 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/83 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
1.4%
1/73 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/83 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
1.4%
1/73 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Infections and infestations
Biliary sepsis
|
0.00%
0/83 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
1.4%
1/73 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Infections and infestations
COVID-19
|
1.2%
1/83 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/83 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
1.4%
1/73 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/83 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
1.4%
1/73 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Hepatobiliary disorders
Cholangitis
|
1.2%
1/83 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
2.7%
2/73 • Number of events 3 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
4.8%
2/42 • Number of events 4 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Hepatobiliary disorders
Cholangitis acute
|
1.2%
1/83 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Infections and infestations
Clostridium difficile infection
|
1.2%
1/83 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Gastrointestinal disorders
Colitis
|
1.2%
1/83 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Gastrointestinal disorders
Constipation
|
1.2%
1/83 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Vascular disorders
Dry gangrene
|
1.2%
1/83 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/83 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
1.4%
1/73 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/83 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
1.4%
1/73 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
General disorders
Fatigue
|
1.2%
1/83 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/83 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
1.4%
1/73 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/83 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
1.4%
1/73 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
1.2%
1/83 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Nervous system disorders
Gliosis
|
1.2%
1/83 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Hepatobiliary disorders
Hepatic pain
|
1.2%
1/83 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
General disorders
Hernia pain
|
1.2%
1/83 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.2%
1/83 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/83 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
1.4%
1/73 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/83 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
1.4%
1/73 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.2%
1/83 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Gastrointestinal disorders
Ileus
|
1.2%
1/83 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Injury, poisoning and procedural complications
Incisional hernia, obstructive
|
1.2%
1/83 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Nervous system disorders
Ischaemic stroke
|
1.2%
1/83 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
2.4%
2/83 • Number of events 2 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Nervous system disorders
Lethargy
|
1.2%
1/83 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/83 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
1.4%
1/73 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Eye disorders
Macular hole
|
1.2%
1/83 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
General disorders
Malaise
|
0.00%
0/83 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
1.4%
1/73 • Number of events 2 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
2.4%
1/42 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Gastrointestinal disorders
Mechanical ileus
|
1.2%
1/83 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Psychiatric disorders
Mental status changes
|
1.2%
1/83 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Nervous system disorders
Migraine
|
1.2%
1/83 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/83 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
2.4%
1/42 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/83 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
1.4%
1/73 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Gastrointestinal disorders
Oesophagitis
|
1.2%
1/83 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Gastrointestinal disorders
Pancreatitis
|
1.2%
1/83 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
1.2%
1/83 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal swelling
|
1.2%
1/83 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Investigations
Platelet count decreased
|
0.00%
0/83 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
2.7%
2/73 • Number of events 4 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.2%
1/83 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Infections and infestations
Pneumonia
|
1.2%
1/83 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Infections and infestations
Pneumonia legionella
|
0.00%
0/83 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
1.4%
1/73 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/83 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
1.4%
1/73 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
2.4%
1/42 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
General disorders
Pyrexia
|
0.00%
0/83 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
1.4%
1/73 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Renal and urinary disorders
Renal failure
|
1.2%
1/83 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
2.4%
1/42 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/83 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
2.4%
1/42 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/83 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
1.4%
1/73 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Eye disorders
Retinal artery occlusion
|
1.2%
1/83 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Eye disorders
Retinal ischaemia
|
1.2%
1/83 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
1.2%
1/83 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Nervous system disorders
Seizure
|
0.00%
0/83 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
1.4%
1/73 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Infections and infestations
Sepsis
|
3.6%
3/83 • Number of events 3 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
2.4%
1/42 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/83 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
1.4%
1/73 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Infections and infestations
Urinary tract infection
|
1.2%
1/83 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
2.4%
1/42 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Infections and infestations
Vascular device infection
|
1.2%
1/83 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
1/83 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/83 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
1.4%
1/73 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
Other adverse events
| Measure |
Randomized Period: Pemigatinib 13.5 mg QD
n=83 participants at risk
Participants received oral pemigatinib 13.5 milligrams (mg) once daily (QD) continuous therapy in 3-week cycles. Treatment continued until disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) assessed by Independent Central Review (ICR), unacceptable toxicity, or another treatment discontinuation criterion was met.
|
Randomized Period: Gemcitabine 1000 mg/m^2 Plus Cisplatin 25 mg/m^2
n=73 participants at risk
Participants received gemcitabine 1000 milligrams per square meter (mg/m\^2) plus cisplatin 25 mg/m\^2 intravenously on Days 1 and 8 every 3 weeks for up to 8 cycles (if 1 cycle was administered prior to randomization, the total of 8 cycles included that prior cycle as well).
|
Transition Period: Pemigatinib 13.5 mg QD
n=42 participants at risk
Participants who received gemcitabine 1000 mg/m\^2 plus cisplatin 25 mg/m\^2 intravenously on Days 1 and 8 every 3 weeks for up to 8 cycles (if 1 cycle was administered prior to randomization, the total of 8 cycles included that prior cycle as well) transitioned to pemigatinib 13.5 mg QD after experiencing disease progression per RECIST v1.1 assessed by ICR.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
13.3%
11/83 • Number of events 13 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
13.7%
10/73 • Number of events 11 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
26.2%
11/42 • Number of events 13 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
13.3%
11/83 • Number of events 12 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
9.6%
7/73 • Number of events 8 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
4.8%
2/42 • Number of events 2 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Nervous system disorders
Ageusia
|
6.0%
5/83 • Number of events 5 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
1.4%
1/73 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
2.4%
1/42 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Investigations
Alanine aminotransferase increased
|
22.9%
19/83 • Number of events 24 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
11.0%
8/73 • Number of events 13 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
14.3%
6/42 • Number of events 10 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
56.6%
47/83 • Number of events 48 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
17.8%
13/73 • Number of events 13 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
50.0%
21/42 • Number of events 21 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Blood and lymphatic system disorders
Anaemia
|
14.5%
12/83 • Number of events 15 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
50.7%
37/73 • Number of events 50 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
11.9%
5/42 • Number of events 5 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.7%
28/83 • Number of events 35 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
5.5%
4/73 • Number of events 4 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
23.8%
10/42 • Number of events 13 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Gastrointestinal disorders
Ascites
|
2.4%
2/83 • Number of events 2 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
5.5%
4/73 • Number of events 4 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
7.1%
3/42 • Number of events 3 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Investigations
Aspartate aminotransferase increased
|
18.1%
15/83 • Number of events 21 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
9.6%
7/73 • Number of events 11 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
11.9%
5/42 • Number of events 10 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
General disorders
Asthenia
|
19.3%
16/83 • Number of events 17 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
20.5%
15/73 • Number of events 27 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
23.8%
10/42 • Number of events 14 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.5%
12/83 • Number of events 14 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
8.2%
6/73 • Number of events 6 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
4.8%
2/42 • Number of events 2 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Eye disorders
Blepharitis
|
2.4%
2/83 • Number of events 2 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
1.4%
1/73 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
7.1%
3/42 • Number of events 3 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Investigations
Blood alkaline phosphatase increased
|
16.9%
14/83 • Number of events 16 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
4.1%
3/73 • Number of events 4 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
2.4%
1/42 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Investigations
Blood bilirubin increased
|
6.0%
5/83 • Number of events 5 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
4.1%
3/73 • Number of events 6 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
7.1%
3/42 • Number of events 7 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Investigations
Blood creatinine increased
|
18.1%
15/83 • Number of events 20 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
4.1%
3/73 • Number of events 3 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
7.1%
3/42 • Number of events 4 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Investigations
Blood phosphorus increased
|
3.6%
3/83 • Number of events 3 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
1.4%
1/73 • Number of events 3 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
7.1%
3/42 • Number of events 3 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Infections and infestations
COVID-19
|
9.6%
8/83 • Number of events 8 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
9.6%
7/73 • Number of events 7 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
14.3%
6/42 • Number of events 6 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Eye disorders
Cataract
|
6.0%
5/83 • Number of events 5 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
2.7%
2/73 • Number of events 2 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
2.4%
1/42 • Number of events 2 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Infections and infestations
Conjunctivitis
|
13.3%
11/83 • Number of events 12 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
2.7%
2/73 • Number of events 2 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
11.9%
5/42 • Number of events 5 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Gastrointestinal disorders
Constipation
|
44.6%
37/83 • Number of events 51 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
35.6%
26/73 • Number of events 31 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
31.0%
13/42 • Number of events 15 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.0%
10/83 • Number of events 10 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
6.8%
5/73 • Number of events 5 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
9.5%
4/42 • Number of events 4 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
22.9%
19/83 • Number of events 19 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
19.2%
14/73 • Number of events 16 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
19.0%
8/42 • Number of events 8 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/83 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
6.8%
5/73 • Number of events 5 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Gastrointestinal disorders
Diarrhoea
|
44.6%
37/83 • Number of events 47 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
16.4%
12/73 • Number of events 18 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
31.0%
13/42 • Number of events 22 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Nervous system disorders
Dizziness
|
6.0%
5/83 • Number of events 5 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
2.7%
2/73 • Number of events 4 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Eye disorders
Dry eye
|
36.1%
30/83 • Number of events 34 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
4.1%
3/73 • Number of events 3 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
23.8%
10/42 • Number of events 12 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Gastrointestinal disorders
Dry mouth
|
33.7%
28/83 • Number of events 33 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
5.5%
4/73 • Number of events 4 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
19.0%
8/42 • Number of events 9 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
18.1%
15/83 • Number of events 18 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
4.1%
3/73 • Number of events 3 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
19.0%
8/42 • Number of events 8 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Nervous system disorders
Dysgeusia
|
37.3%
31/83 • Number of events 32 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
11.0%
8/73 • Number of events 9 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
35.7%
15/42 • Number of events 19 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/83 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
1.4%
1/73 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
7.1%
3/42 • Number of events 3 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.6%
3/83 • Number of events 3 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
9.6%
7/73 • Number of events 7 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
4.8%
2/42 • Number of events 2 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/83 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
9.5%
4/42 • Number of events 4 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
18.1%
15/83 • Number of events 21 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
4.1%
3/73 • Number of events 3 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
11.9%
5/42 • Number of events 7 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
General disorders
Fatigue
|
20.5%
17/83 • Number of events 19 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
42.5%
31/73 • Number of events 35 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
23.8%
10/42 • Number of events 10 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Gastrointestinal disorders
Haemorrhoids
|
6.0%
5/83 • Number of events 5 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
1.4%
1/73 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
7.1%
3/42 • Number of events 3 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Nervous system disorders
Headache
|
6.0%
5/83 • Number of events 6 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
11.0%
8/73 • Number of events 10 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
4.8%
2/42 • Number of events 2 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
2.4%
2/83 • Number of events 3 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
5.5%
4/73 • Number of events 6 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
8.4%
7/83 • Number of events 12 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
1.4%
1/73 • Number of events 2 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
9.5%
4/42 • Number of events 4 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
81.9%
68/83 • Number of events 121 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
2.7%
2/73 • Number of events 2 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
88.1%
37/42 • Number of events 59 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Vascular disorders
Hypertension
|
6.0%
5/83 • Number of events 10 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
6.8%
5/73 • Number of events 5 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
9.5%
4/42 • Number of events 4 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
8.4%
7/83 • Number of events 8 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
12.3%
9/73 • Number of events 13 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
2.4%
1/42 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
9.6%
8/83 • Number of events 10 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
2.4%
1/42 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
13.3%
11/83 • Number of events 19 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
1.4%
1/73 • Number of events 2 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
21.4%
9/42 • Number of events 13 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Vascular disorders
Hypotension
|
6.0%
5/83 • Number of events 5 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Psychiatric disorders
Insomnia
|
6.0%
5/83 • Number of events 5 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
5.5%
4/73 • Number of events 4 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Eye disorders
Keratitis
|
10.8%
9/83 • Number of events 10 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
1.4%
1/73 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
7.1%
3/42 • Number of events 3 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/83 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
9.6%
7/73 • Number of events 10 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Madarosis
|
8.4%
7/83 • Number of events 8 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
General disorders
Malaise
|
3.6%
3/83 • Number of events 5 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
9.6%
7/73 • Number of events 10 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
General disorders
Mucosal inflammation
|
3.6%
3/83 • Number of events 3 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
1.4%
1/73 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
14.3%
6/42 • Number of events 8 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.0%
5/83 • Number of events 6 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
2.7%
2/73 • Number of events 3 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
4.8%
2/42 • Number of events 3 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.6%
8/83 • Number of events 10 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
4.1%
3/73 • Number of events 4 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
2.4%
1/42 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
12.0%
10/83 • Number of events 11 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
11.9%
5/42 • Number of events 5 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
28.9%
24/83 • Number of events 27 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
21.4%
9/42 • Number of events 10 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Nail dystrophy
|
7.2%
6/83 • Number of events 7 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
4.8%
2/42 • Number of events 2 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Infections and infestations
Nail infection
|
7.2%
6/83 • Number of events 7 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
7.1%
3/42 • Number of events 3 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Nail toxicity
|
6.0%
5/83 • Number of events 5 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
7.1%
3/42 • Number of events 4 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Gastrointestinal disorders
Nausea
|
20.5%
17/83 • Number of events 23 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
49.3%
36/73 • Number of events 58 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
14.3%
6/42 • Number of events 8 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/83 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
30.1%
22/73 • Number of events 50 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
7.1%
3/42 • Number of events 4 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Investigations
Neutrophil count decreased
|
3.6%
3/83 • Number of events 6 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
20.5%
15/73 • Number of events 39 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Eye disorders
Ocular hyperaemia
|
7.2%
6/83 • Number of events 6 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
2.4%
1/42 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
General disorders
Oedema peripheral
|
9.6%
8/83 • Number of events 8 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
15.1%
11/73 • Number of events 14 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
7.1%
3/42 • Number of events 3 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
14.5%
12/83 • Number of events 14 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
21.4%
9/42 • Number of events 9 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
14.5%
12/83 • Number of events 12 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
11.9%
5/42 • Number of events 5 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Infections and infestations
Onychomycosis
|
4.8%
4/83 • Number of events 4 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
7.1%
3/42 • Number of events 3 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.2%
6/83 • Number of events 8 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
5.5%
4/73 • Number of events 6 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
14.3%
6/42 • Number of events 6 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
47.0%
39/83 • Number of events 49 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
2.7%
2/73 • Number of events 2 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
38.1%
16/42 • Number of events 22 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Nervous system disorders
Paraesthesia
|
1.2%
1/83 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
6.8%
5/73 • Number of events 7 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
7.1%
3/42 • Number of events 3 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Infections and infestations
Paronychia
|
6.0%
5/83 • Number of events 5 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
14.3%
6/42 • Number of events 6 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.4%
2/83 • Number of events 3 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
6.8%
5/73 • Number of events 5 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
2.4%
1/42 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Eye disorders
Photophobia
|
1.2%
1/83 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
7.1%
3/42 • Number of events 3 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Investigations
Platelet count decreased
|
1.2%
1/83 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
27.4%
20/73 • Number of events 34 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
4.8%
2/42 • Number of events 2 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.4%
7/83 • Number of events 9 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
2.7%
2/73 • Number of events 2 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/83 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
5.5%
4/73 • Number of events 4 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
General disorders
Pyrexia
|
9.6%
8/83 • Number of events 10 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
13.7%
10/73 • Number of events 13 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
14.3%
6/42 • Number of events 9 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.6%
8/83 • Number of events 8 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
4.1%
3/73 • Number of events 3 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
2.4%
1/42 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Gastrointestinal disorders
Stomatitis
|
45.8%
38/83 • Number of events 57 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
16.4%
12/73 • Number of events 12 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
47.6%
20/42 • Number of events 31 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Nervous system disorders
Taste disorder
|
3.6%
3/83 • Number of events 3 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
7.1%
3/42 • Number of events 4 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/83 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
19.2%
14/73 • Number of events 25 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
14.3%
6/42 • Number of events 8 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Eye disorders
Trichiasis
|
13.3%
11/83 • Number of events 11 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
4.8%
2/42 • Number of events 2 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Infections and infestations
Urinary tract infection
|
9.6%
8/83 • Number of events 13 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
4.1%
3/73 • Number of events 3 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
4.8%
2/42 • Number of events 3 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Eye disorders
Vision blurred
|
8.4%
7/83 • Number of events 7 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
1.4%
1/73 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
16.7%
7/42 • Number of events 7 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Investigations
Vitamin D decreased
|
6.0%
5/83 • Number of events 5 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
2.7%
2/73 • Number of events 2 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
2.4%
1/42 • Number of events 1 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
9.6%
8/83 • Number of events 8 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/73 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
9.5%
4/42 • Number of events 4 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Gastrointestinal disorders
Vomiting
|
12.0%
10/83 • Number of events 10 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
24.7%
18/73 • Number of events 26 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
4.8%
2/42 • Number of events 4 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Investigations
Weight decreased
|
7.2%
6/83 • Number of events 7 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
11.0%
8/73 • Number of events 8 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
|
Investigations
White blood cell count decreased
|
3.6%
3/83 • Number of events 10 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
8.2%
6/73 • Number of events 11 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
0.00%
0/42 • up to approximately 6 years
Adverse events have been reported for the Safety Population (all randomized participants who received ≥1 dose of study drug) and the Crossover Evaluable Population (all participants who received ≥1 dose of pemigatinib after switch from the gemcitabine plus cisplatin group). Deaths have been reported for all randomized participants.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
- Publication restrictions are in place
Restriction type: OTHER