Trial Outcomes & Findings for Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Relapsed or Refractory Advanced Non-Small Cell Lung Cancer With an FGFR Alteration (NCT NCT05253807)
NCT ID: NCT05253807
Last Updated: 2025-08-05
Results Overview
ORR was defined as the percentage of participants who achieved a complete response (CR) or a partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Response was determined by an Independent Central Radiology (ICR) review. 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.
COMPLETED
PHASE2
8 participants
up to 267 days
2025-08-05
Participant Flow
This study was conducted at 8 study centers in Spain, Italy, France, and the United States.
Participant milestones
| Measure |
Cohort A: Squamous NSCLC
Participants with squamous non-small cell lung cancer (NSCLC) with known or likely fibroblast growth factor receptor 1, 2, or 3 (FGFR1-3) driver mutations outside the kinase domain or fusions/rearrangements self-administered pemigatinib 13.5 milligrams (mg) (starting dose) as a once daily (QD) oral treatment on a 21-day cycle. Participants took study drug every day on an intermittent dose regimen (2 weeks on treatment, followed by no study drug for 1 week \[dose holiday\]), until documented disease progression or unacceptable toxicity was reported.
|
Cohort B: Nonsquamous NSCLC
Cohort B: Nonsquamous NSCLC (Experimental) Participants with nonsquamous NSCLC with known or likely FGFR1-3 driver mutations outside the kinase domain or fusions/rearrangements, including participants who had relapsed on prior targeted therapy, self-administered pemigatinib 13.5 mg (starting dose) as a QD oral treatment on a 21-day cycle. Participants took study drug every day on an intermittent dose regimen (2 weeks on treatment, followed by no study drug for 1 week \[dose holiday\]), until documented disease progression or unacceptable toxicity was reported.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
5
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
| Measure |
Cohort A: Squamous NSCLC
Participants with squamous non-small cell lung cancer (NSCLC) with known or likely fibroblast growth factor receptor 1, 2, or 3 (FGFR1-3) driver mutations outside the kinase domain or fusions/rearrangements self-administered pemigatinib 13.5 milligrams (mg) (starting dose) as a once daily (QD) oral treatment on a 21-day cycle. Participants took study drug every day on an intermittent dose regimen (2 weeks on treatment, followed by no study drug for 1 week \[dose holiday\]), until documented disease progression or unacceptable toxicity was reported.
|
Cohort B: Nonsquamous NSCLC
Cohort B: Nonsquamous NSCLC (Experimental) Participants with nonsquamous NSCLC with known or likely FGFR1-3 driver mutations outside the kinase domain or fusions/rearrangements, including participants who had relapsed on prior targeted therapy, self-administered pemigatinib 13.5 mg (starting dose) as a QD oral treatment on a 21-day cycle. Participants took study drug every day on an intermittent dose regimen (2 weeks on treatment, followed by no study drug for 1 week \[dose holiday\]), until documented disease progression or unacceptable toxicity was reported.
|
|---|---|---|
|
Overall Study
Death
|
1
|
4
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Study Terminated by Sponsor
|
1
|
1
|
Baseline Characteristics
Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Relapsed or Refractory Advanced Non-Small Cell Lung Cancer With an FGFR Alteration
Baseline characteristics by cohort
| Measure |
Cohort A: Squamous NSCLC
n=3 Participants
Participants with squamous non-small cell lung cancer (NSCLC) with known or likely fibroblast growth factor receptor 1, 2, or 3 (FGFR1-3) driver mutations outside the kinase domain or fusions/rearrangements self-administered pemigatinib 13.5 milligrams (mg) (starting dose) as a once daily (QD) oral treatment on a 21-day cycle. Participants took study drug every day on an intermittent dose regimen (2 weeks on treatment, followed by no study drug for 1 week \[dose holiday\]), until documented disease progression or unacceptable toxicity was reported.
|
Cohort B: Nonsquamous NSCLC
n=5 Participants
Cohort B: Nonsquamous NSCLC (Experimental) Participants with nonsquamous NSCLC with known or likely FGFR1-3 driver mutations outside the kinase domain or fusions/rearrangements, including participants who had relapsed on prior targeted therapy, self-administered pemigatinib 13.5 mg (starting dose) as a QD oral treatment on a 21-day cycle. Participants took study drug every day on an intermittent dose regimen (2 weeks on treatment, followed by no study drug for 1 week \[dose holiday\]), until documented disease progression or unacceptable toxicity was reported.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 267 daysPopulation: Full Analysis Population: all enrolled participants who received at least 1 dose of pemigatinib. The confidence interval was calculated based on the exact method for binomial distribution.
ORR was defined as the percentage of participants who achieved a complete response (CR) or a partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Response was determined by an Independent Central Radiology (ICR) review. 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 |
Cohort A: Squamous NSCLC
n=3 Participants
Participants with squamous non-small cell lung cancer (NSCLC) with known or likely fibroblast growth factor receptor 1, 2, or 3 (FGFR1-3) driver mutations outside the kinase domain or fusions/rearrangements self-administered pemigatinib 13.5 milligrams (mg) (starting dose) as a once daily (QD) oral treatment on a 21-day cycle. Participants took study drug every day on an intermittent dose regimen (2 weeks on treatment, followed by no study drug for 1 week \[dose holiday\]), until documented disease progression or unacceptable toxicity was reported.
|
Cohort B: Nonsquamous NSCLC
Participants with nonsquamous NSCLC with known or likely FGFR1-3 driver mutations outside the kinase domain or fusions/rearrangements, including participants who had relapsed on prior targeted therapy, self-administered pemigatinib 13.5 mg (starting dose) as a QD oral treatment on a 21-day cycle. Participants took study drug every day on an intermittent dose regimen (2 weeks on treatment, followed by no study drug for 1 week \[dose holiday\]), until documented disease progression or unacceptable toxicity was reported.
|
|---|---|---|
|
Objective Response Rate (ORR) in Cohort A
|
33.3 percentage of participants
Interval 0.84 to 90.57
|
—
|
SECONDARY outcome
Timeframe: up to 80 daysPopulation: Full Analysis Population. The confidence interval was calculated based on the exact method for binomial distribution.
ORR was defined as the percentage of participants who achieved a CR or PR based on RECIST v1.1. Response was determined by an ICR review. 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 |
Cohort A: Squamous NSCLC
Participants with squamous non-small cell lung cancer (NSCLC) with known or likely fibroblast growth factor receptor 1, 2, or 3 (FGFR1-3) driver mutations outside the kinase domain or fusions/rearrangements self-administered pemigatinib 13.5 milligrams (mg) (starting dose) as a once daily (QD) oral treatment on a 21-day cycle. Participants took study drug every day on an intermittent dose regimen (2 weeks on treatment, followed by no study drug for 1 week \[dose holiday\]), until documented disease progression or unacceptable toxicity was reported.
|
Cohort B: Nonsquamous NSCLC
n=5 Participants
Participants with nonsquamous NSCLC with known or likely FGFR1-3 driver mutations outside the kinase domain or fusions/rearrangements, including participants who had relapsed on prior targeted therapy, self-administered pemigatinib 13.5 mg (starting dose) as a QD oral treatment on a 21-day cycle. Participants took study drug every day on an intermittent dose regimen (2 weeks on treatment, followed by no study drug for 1 week \[dose holiday\]), until documented disease progression or unacceptable toxicity was reported.
|
|---|---|---|
|
ORR in Cohort B
|
—
|
0.0 percentage of participants
Interval 0.0 to 52.18
|
SECONDARY outcome
Timeframe: up to 267 daysPopulation: Full Analysis Population. The 95% confidence interval was calculated using the Brookmeyer and Crowley's method.
PFS was defined as the time from the first dose of study treatment until progressive disease (PD) (according to RECIST v1.1 as assessed by an ICR review) or death, whichever occurred first. PD was defined as the progression of a target or non-target lesion or presence of a new lesion.
Outcome measures
| Measure |
Cohort A: Squamous NSCLC
n=3 Participants
Participants with squamous non-small cell lung cancer (NSCLC) with known or likely fibroblast growth factor receptor 1, 2, or 3 (FGFR1-3) driver mutations outside the kinase domain or fusions/rearrangements self-administered pemigatinib 13.5 milligrams (mg) (starting dose) as a once daily (QD) oral treatment on a 21-day cycle. Participants took study drug every day on an intermittent dose regimen (2 weeks on treatment, followed by no study drug for 1 week \[dose holiday\]), until documented disease progression or unacceptable toxicity was reported.
|
Cohort B: Nonsquamous NSCLC
Participants with nonsquamous NSCLC with known or likely FGFR1-3 driver mutations outside the kinase domain or fusions/rearrangements, including participants who had relapsed on prior targeted therapy, self-administered pemigatinib 13.5 mg (starting dose) as a QD oral treatment on a 21-day cycle. Participants took study drug every day on an intermittent dose regimen (2 weeks on treatment, followed by no study drug for 1 week \[dose holiday\]), until documented disease progression or unacceptable toxicity was reported.
|
|---|---|---|
|
Progression-free Survival (PFS) in Cohort A
|
8.31 months
Interval 5.19 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 182 daysPopulation: Full Analysis Population. Only those participants with available data were analyzed. The 95% confidence interval was calculated using the Brookmeyer and Crowley's method.
DOR was defined as the time from the date of the first CR or PR until the date of the first PD (according to RECIST v1.1 as assessed by an ICR review) 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 |
Cohort A: Squamous NSCLC
n=1 Participants
Participants with squamous non-small cell lung cancer (NSCLC) with known or likely fibroblast growth factor receptor 1, 2, or 3 (FGFR1-3) driver mutations outside the kinase domain or fusions/rearrangements self-administered pemigatinib 13.5 milligrams (mg) (starting dose) as a once daily (QD) oral treatment on a 21-day cycle. Participants took study drug every day on an intermittent dose regimen (2 weeks on treatment, followed by no study drug for 1 week \[dose holiday\]), until documented disease progression or unacceptable toxicity was reported.
|
Cohort B: Nonsquamous NSCLC
Participants with nonsquamous NSCLC with known or likely FGFR1-3 driver mutations outside the kinase domain or fusions/rearrangements, including participants who had relapsed on prior targeted therapy, self-administered pemigatinib 13.5 mg (starting dose) as a QD oral treatment on a 21-day cycle. Participants took study drug every day on an intermittent dose regimen (2 weeks on treatment, followed by no study drug for 1 week \[dose holiday\]), until documented disease progression or unacceptable toxicity was reported.
|
|---|---|---|
|
Duration of Response (DOR) in Cohort A
|
NA months
The median and the upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
|
—
|
SECONDARY outcome
Timeframe: up to 267 daysPopulation: Full Analysis Population. The 95% confidence interval was calculated using the Brookmeyer and Crowley's method.
OS was defined as the time from the first dose of study treatment to death of any cause.
Outcome measures
| Measure |
Cohort A: Squamous NSCLC
n=3 Participants
Participants with squamous non-small cell lung cancer (NSCLC) with known or likely fibroblast growth factor receptor 1, 2, or 3 (FGFR1-3) driver mutations outside the kinase domain or fusions/rearrangements self-administered pemigatinib 13.5 milligrams (mg) (starting dose) as a once daily (QD) oral treatment on a 21-day cycle. Participants took study drug every day on an intermittent dose regimen (2 weeks on treatment, followed by no study drug for 1 week \[dose holiday\]), until documented disease progression or unacceptable toxicity was reported.
|
Cohort B: Nonsquamous NSCLC
Participants with nonsquamous NSCLC with known or likely FGFR1-3 driver mutations outside the kinase domain or fusions/rearrangements, including participants who had relapsed on prior targeted therapy, self-administered pemigatinib 13.5 mg (starting dose) as a QD oral treatment on a 21-day cycle. Participants took study drug every day on an intermittent dose regimen (2 weeks on treatment, followed by no study drug for 1 week \[dose holiday\]), until documented disease progression or unacceptable toxicity was reported.
|
|---|---|---|
|
Overall Survival (OS) in Cohort A
|
NA months
Interval 5.19 to
The median and the upper limit of the confidence interval were not estimable because too few participants died.
|
—
|
SECONDARY outcome
Timeframe: up to 302 daysPopulation: Safety Population: all enrolled participants who received at least 1 dose of pemigatinib
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as an AE that was reported for the first time or the worsening of a pre-existing event after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib.
Outcome measures
| Measure |
Cohort A: Squamous NSCLC
n=3 Participants
Participants with squamous non-small cell lung cancer (NSCLC) with known or likely fibroblast growth factor receptor 1, 2, or 3 (FGFR1-3) driver mutations outside the kinase domain or fusions/rearrangements self-administered pemigatinib 13.5 milligrams (mg) (starting dose) as a once daily (QD) oral treatment on a 21-day cycle. Participants took study drug every day on an intermittent dose regimen (2 weeks on treatment, followed by no study drug for 1 week \[dose holiday\]), until documented disease progression or unacceptable toxicity was reported.
|
Cohort B: Nonsquamous NSCLC
n=5 Participants
Participants with nonsquamous NSCLC with known or likely FGFR1-3 driver mutations outside the kinase domain or fusions/rearrangements, including participants who had relapsed on prior targeted therapy, self-administered pemigatinib 13.5 mg (starting dose) as a QD oral treatment on a 21-day cycle. Participants took study drug every day on an intermittent dose regimen (2 weeks on treatment, followed by no study drug for 1 week \[dose holiday\]), until documented disease progression or unacceptable toxicity was reported.
|
|---|---|---|
|
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: up to 302 daysPopulation: Safety Population
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as an AE that was reported for the first time or the worsening of a pre-existing event after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib. The investigator assessed the relationship between study drug and each occurrence of each AE/serious adverse event.
Outcome measures
| Measure |
Cohort A: Squamous NSCLC
n=3 Participants
Participants with squamous non-small cell lung cancer (NSCLC) with known or likely fibroblast growth factor receptor 1, 2, or 3 (FGFR1-3) driver mutations outside the kinase domain or fusions/rearrangements self-administered pemigatinib 13.5 milligrams (mg) (starting dose) as a once daily (QD) oral treatment on a 21-day cycle. Participants took study drug every day on an intermittent dose regimen (2 weeks on treatment, followed by no study drug for 1 week \[dose holiday\]), until documented disease progression or unacceptable toxicity was reported.
|
Cohort B: Nonsquamous NSCLC
n=5 Participants
Participants with nonsquamous NSCLC with known or likely FGFR1-3 driver mutations outside the kinase domain or fusions/rearrangements, including participants who had relapsed on prior targeted therapy, self-administered pemigatinib 13.5 mg (starting dose) as a QD oral treatment on a 21-day cycle. Participants took study drug every day on an intermittent dose regimen (2 weeks on treatment, followed by no study drug for 1 week \[dose holiday\]), until documented disease progression or unacceptable toxicity was reported.
|
|---|---|---|
|
Number of Participants With Any Treatment-related TEAE According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0
|
3 Participants
|
5 Participants
|
Adverse Events
Cohort A: Squamous NSCLC
Cohort B: Nonsquamous NSCLC
Total
Serious adverse events
| Measure |
Cohort A: Squamous NSCLC
n=3 participants at risk
Participants with squamous non-small cell lung cancer (NSCLC) with known or likely fibroblast growth factor receptor 1, 2, or 3 (FGFR1-3) driver mutations outside the kinase domain or fusions/rearrangements self-administered pemigatinib 13.5 milligrams (mg) (starting dose) as a once daily (QD) oral treatment on a 21-day cycle. Participants took study drug every day on an intermittent dose regimen (2 weeks on treatment, followed by no study drug for 1 week \[dose holiday\]), until documented disease progression or unacceptable toxicity was reported.
|
Cohort B: Nonsquamous NSCLC
n=5 participants at risk
Participants with nonsquamous NSCLC with known or likely FGFR1-3 driver mutations outside the kinase domain or fusions/rearrangements, including participants who had relapsed on prior targeted therapy, self-administered pemigatinib 13.5 mg (starting dose) as a QD oral treatment on a 21-day cycle. Participants took study drug every day on an intermittent dose regimen (2 weeks on treatment, followed by no study drug for 1 week \[dose holiday\]), until documented disease progression or unacceptable toxicity was reported.
|
Total
n=8 participants at risk
Total
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/3 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
20.0%
1/5 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
20.0%
1/5 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
20.0%
1/5 • Number of events 2 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 2 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/3 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
20.0%
1/5 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/3 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
20.0%
1/5 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
Other adverse events
| Measure |
Cohort A: Squamous NSCLC
n=3 participants at risk
Participants with squamous non-small cell lung cancer (NSCLC) with known or likely fibroblast growth factor receptor 1, 2, or 3 (FGFR1-3) driver mutations outside the kinase domain or fusions/rearrangements self-administered pemigatinib 13.5 milligrams (mg) (starting dose) as a once daily (QD) oral treatment on a 21-day cycle. Participants took study drug every day on an intermittent dose regimen (2 weeks on treatment, followed by no study drug for 1 week \[dose holiday\]), until documented disease progression or unacceptable toxicity was reported.
|
Cohort B: Nonsquamous NSCLC
n=5 participants at risk
Participants with nonsquamous NSCLC with known or likely FGFR1-3 driver mutations outside the kinase domain or fusions/rearrangements, including participants who had relapsed on prior targeted therapy, self-administered pemigatinib 13.5 mg (starting dose) as a QD oral treatment on a 21-day cycle. Participants took study drug every day on an intermittent dose regimen (2 weeks on treatment, followed by no study drug for 1 week \[dose holiday\]), until documented disease progression or unacceptable toxicity was reported.
|
Total
n=8 participants at risk
Total
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Pustular psoriasis
|
0.00%
0/3 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
20.0%
1/5 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
20.0%
1/5 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/3 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
20.0%
1/5 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
20.0%
1/5 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
1/3 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
20.0%
1/5 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
25.0%
2/8 • Number of events 2 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Investigations
Amylase increased
|
0.00%
0/3 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
20.0%
1/5 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Gastrointestinal disorders
Anorectal discomfort
|
33.3%
1/3 • Number of events 2 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
0.00%
0/5 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 2 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
66.7%
2/3 • Number of events 2 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
0.00%
0/5 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
25.0%
2/8 • Number of events 2 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
20.0%
1/5 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
General disorders
Asthenia
|
0.00%
0/3 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
40.0%
2/5 • Number of events 2 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
25.0%
2/8 • Number of events 2 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
0.00%
0/5 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Investigations
Blood creatinine increased
|
33.3%
1/3 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
40.0%
2/5 • Number of events 2 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
37.5%
3/8 • Number of events 3 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Investigations
Blood glucose increased
|
33.3%
1/3 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
0.00%
0/5 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Investigations
Blood phosphorus increased
|
0.00%
0/3 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
20.0%
1/5 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Bone disorder
|
33.3%
1/3 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
0.00%
0/5 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Eye disorders
Cataract
|
33.3%
1/3 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
0.00%
0/5 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Infections and infestations
Cellulitis
|
33.3%
1/3 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
0.00%
0/5 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
General disorders
Chills
|
33.3%
1/3 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
0.00%
0/5 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
20.0%
1/5 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Injury, poisoning and procedural complications
Contusion
|
33.3%
1/3 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
0.00%
0/5 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
20.0%
1/5 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
40.0%
2/5 • Number of events 2 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
25.0%
2/8 • Number of events 2 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
20.0%
1/5 • Number of events 5 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 5 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/3 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
20.0%
1/5 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Gastrointestinal disorders
Diarrhoea
|
66.7%
2/3 • Number of events 8 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
60.0%
3/5 • Number of events 3 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
62.5%
5/8 • Number of events 11 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Eye disorders
Dry eye
|
33.3%
1/3 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
0.00%
0/5 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
20.0%
1/5 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
33.3%
1/3 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
0.00%
0/5 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
20.0%
1/5 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
1/3 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
20.0%
1/5 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
25.0%
2/8 • Number of events 2 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
20.0%
1/5 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
33.3%
1/3 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
0.00%
0/5 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
33.3%
1/3 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
0.00%
0/5 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
33.3%
1/3 • Number of events 3 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
0.00%
0/5 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 3 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Gastrointestinal disorders
Gingival bleeding
|
33.3%
1/3 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
0.00%
0/5 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Gastrointestinal disorders
Gingival pain
|
33.3%
1/3 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
0.00%
0/5 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Gastrointestinal disorders
Glossodynia
|
33.3%
1/3 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
0.00%
0/5 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
33.3%
1/3 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
0.00%
0/5 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
33.3%
1/3 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
40.0%
2/5 • Number of events 3 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
37.5%
3/8 • Number of events 4 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
100.0%
3/3 • Number of events 4 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
60.0%
3/5 • Number of events 4 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
75.0%
6/8 • Number of events 8 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
20.0%
1/5 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
20.0%
1/5 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
40.0%
2/5 • Number of events 3 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
25.0%
2/8 • Number of events 3 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
20.0%
1/5 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Investigations
Lipase increased
|
0.00%
0/3 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
40.0%
2/5 • Number of events 2 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
25.0%
2/8 • Number of events 2 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/3 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
20.0%
1/5 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
20.0%
1/5 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
66.7%
2/3 • Number of events 2 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
0.00%
0/5 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
25.0%
2/8 • Number of events 2 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Nail dystrophy
|
0.00%
0/3 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
20.0%
1/5 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
20.0%
1/5 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
25.0%
2/8 • Number of events 2 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
20.0%
1/5 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Renal and urinary disorders
Nephropathy
|
0.00%
0/3 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
20.0%
1/5 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Onychalgia
|
33.3%
1/3 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
0.00%
0/5 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
20.0%
1/5 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
66.7%
2/3 • Number of events 3 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
0.00%
0/5 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
25.0%
2/8 • Number of events 3 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Infections and infestations
Pharyngitis bacterial
|
0.00%
0/3 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
20.0%
1/5 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Investigations
Prostatic specific antigen increased
|
33.3%
1/3 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
0.00%
0/5 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
0.00%
0/5 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
20.0%
1/5 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Rash
|
66.7%
2/3 • Number of events 2 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
20.0%
1/5 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
37.5%
3/8 • Number of events 3 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer haemorrhage
|
0.00%
0/3 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
20.0%
1/5 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
20.0%
1/5 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Infections and infestations
Spinal cord infection
|
0.00%
0/3 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
20.0%
1/5 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/3 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
20.0%
1/5 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Gastrointestinal disorders
Stomatitis
|
66.7%
2/3 • Number of events 3 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
40.0%
2/5 • Number of events 2 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
50.0%
4/8 • Number of events 5 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Gastrointestinal disorders
Toothache
|
33.3%
1/3 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
0.00%
0/5 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Infections and infestations
Upper respiratory tract infection
|
33.3%
1/3 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
0.00%
0/5 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Infections and infestations
Urinary tract infection
|
33.3%
1/3 • Number of events 2 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
20.0%
1/5 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
25.0%
2/8 • Number of events 3 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
General disorders
Vaccination site pain
|
33.3%
1/3 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
0.00%
0/5 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
20.0%
1/5 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Eye disorders
Visual impairment
|
33.3%
1/3 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
0.00%
0/5 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/3 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
20.0%
1/5 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Number of events 2 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
20.0%
1/5 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
25.0%
2/8 • Number of events 3 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
Investigations
Weight decreased
|
33.3%
1/3 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
0.00%
0/5 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
|
General disorders
Xerosis
|
0.00%
0/3 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
20.0%
1/5 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
12.5%
1/8 • Number of events 1 • up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
|
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