Trial Outcomes & Findings for A Phase II, Single Arm Study of BGJ398 in Patients With Advanced Cholangiocarcinoma (NCT NCT02150967)
NCT ID: NCT02150967
Last Updated: 2023-07-03
Results Overview
ORR is defined as the percentage (%) of subjects with a best overall response of Complete Response (CR) or Partial Response (PR), as per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1, evaluated by computed tomography (CT) or magnetic resonance imaging (MRI) scans every 28 days. RECIST (v1.1) response criteria were as follows: CR: disappearance of all target lesions. Any pathological lymph node (whether target or non-target) must have reduction in short axis to \<10 mm. PR: at least a 30% decrease from baseline in the sum of diameters of all target lesions. Note: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusions). Results were previously disclosed (22 June 2022). There are no additional efficacy endpoints to assess for Cohort 1, thus efficacy data were not re-analyzed for the final analysis. Due to early termination of the study, no formal efficacy analyses were performed for Cohorts 2 and 3.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
143 participants
Primary outcome timeframe
Analysis was conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021.
Results posted on
2023-07-03
Participant Flow
Participants with a diagnosis of advanced or metastatic cholangiocarcinoma were recruited to this open-label, single-arm global study across 20 centers (9 in the US, 5 in W. Europe, 6 in Asia) based on documented evidence of FGFR gene alteration. The first participant was treated on 23 July 2014. The data cutoff for the primary analysis (Cohort 1 only) was 01 March 2021.The data cutoff for the final analysis (Cohort 2 and 3 only) was 07 February 2022.
Subjects meeting inclusion/exclusion criteria were enrolled into the following cohorts: Cohort 1 (FGFR2 fusions): Primary analysis population (N=108). Cohort 2 (Other FGFR alterations): N=25. Cohort 3 (FGFR2 fusions and prior FGFR inhibitor): N=10. Note: Primary efficacy outcome measures were prespecified only for Cohort 1. Cohorts 2 and 3 were added following PA 4 to support exploratory objectives only. Cohorts 2 and 3 are not the primary analysis population.
Participant milestones
| Measure |
Cohort 1: FGFR2 Fusions
Infigratinib 125 mg once daily (3 wk on/1 wk off treatment)
|
Cohort 2: Other FGFR Alterations
Infigratinib 125 mg once daily (3 wk on/1 wk off treatment)
|
Cohort 3: FGFR2 Fusions and Prior FGFR Inhibitor
Infigratinib 125 mg once daily (3 wk on/1 wk off treatment)
|
|---|---|---|---|
|
Overall Study
STARTED
|
108
|
25
|
10
|
|
Overall Study
Treatment Ongoing
|
0
|
0
|
0
|
|
Overall Study
Treatment Ended
|
108
|
25
|
10
|
|
Overall Study
COMPLETED
|
108
|
25
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The date of most recent recurrence/progression is based on medical history which may not have been available for all patients.
Baseline characteristics by cohort
| Measure |
Cohort 1: FGFR2 Fusions
n=108 Participants
Infigratinib 125 mg once daily (3 wk on/1 wk off treatment)
|
Cohort 2: Other FGFR Genetic Alterations
n=25 Participants
Infigratinib 125 mg once daily (3 wk on/1 wk off treatment)
|
Cohort 3: FGFR2 Fusions and Prior FGFR Inhibitor
n=10 Participants
Infigratinib 125 mg once daily (3 wk on/1 wk off treatment)
|
Total
n=143 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=108 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=143 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
82 Participants
n=108 Participants
|
17 Participants
n=25 Participants
|
8 Participants
n=10 Participants
|
107 Participants
n=143 Participants
|
|
Age, Categorical
>=65 years
|
26 Participants
n=108 Participants
|
8 Participants
n=25 Participants
|
2 Participants
n=10 Participants
|
36 Participants
n=143 Participants
|
|
Age, Continuous
|
53.4 years
STANDARD_DEVIATION 13.08 • n=108 Participants
|
59.9 years
STANDARD_DEVIATION 9.89 • n=25 Participants
|
51.8 years
STANDARD_DEVIATION 12.07 • n=10 Participants
|
54.0 years
STANDARD_DEVIATION 12.88 • n=143 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=108 Participants
|
12 Participants
n=25 Participants
|
3 Participants
n=10 Participants
|
82 Participants
n=143 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=108 Participants
|
13 Participants
n=25 Participants
|
7 Participants
n=10 Participants
|
61 Participants
n=143 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=108 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=143 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=108 Participants
|
2 Participants
n=25 Participants
|
0 Participants
n=10 Participants
|
13 Participants
n=143 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=108 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=143 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=108 Participants
|
1 Participants
n=25 Participants
|
2 Participants
n=10 Participants
|
7 Participants
n=143 Participants
|
|
Race (NIH/OMB)
White
|
78 Participants
n=108 Participants
|
22 Participants
n=25 Participants
|
8 Participants
n=10 Participants
|
108 Participants
n=143 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=108 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=143 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
15 Participants
n=108 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=10 Participants
|
15 Participants
n=143 Participants
|
|
Region of Enrollment
North America
|
77 Participants
n=108 Participants
|
12 Participants
n=25 Participants
|
5 Participants
n=10 Participants
|
94 Participants
n=143 Participants
|
|
Region of Enrollment
Europe
|
24 Participants
n=108 Participants
|
11 Participants
n=25 Participants
|
5 Participants
n=10 Participants
|
40 Participants
n=143 Participants
|
|
Region of Enrollment
South Korea
|
0 Participants
n=108 Participants
|
1 Participants
n=25 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=143 Participants
|
|
Region of Enrollment
Singapore
|
4 Participants
n=108 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=10 Participants
|
4 Participants
n=143 Participants
|
|
Region of Enrollment
Taiwan
|
1 Participants
n=108 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=143 Participants
|
|
Region of Enrollment
Thailand
|
2 Participants
n=108 Participants
|
1 Participants
n=25 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=143 Participants
|
|
ECOG PS
0
|
45 Participants
n=108 Participants
|
11 Participants
n=25 Participants
|
3 Participants
n=10 Participants
|
59 Participants
n=143 Participants
|
|
ECOG PS
1
|
62 Participants
n=108 Participants
|
13 Participants
n=25 Participants
|
7 Participants
n=10 Participants
|
82 Participants
n=143 Participants
|
|
ECOG PS
2
|
1 Participants
n=108 Participants
|
1 Participants
n=25 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=143 Participants
|
|
Primary site of cancer
Bile Duct
|
105 Participants
n=108 Participants
|
24 Participants
n=25 Participants
|
10 Participants
n=10 Participants
|
139 Participants
n=143 Participants
|
|
Primary site of cancer
Cholangiocarcinoma
|
1 Participants
n=108 Participants
|
1 Participants
n=25 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=143 Participants
|
|
Primary site of cancer
Liver
|
2 Participants
n=108 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=143 Participants
|
|
Non-Liver Metastatic Site
No metastatic site
|
5 Participants
n=108 Participants
|
4 Participants
n=25 Participants
|
0 Participants
n=10 Participants
|
9 Participants
n=143 Participants
|
|
Non-Liver Metastatic Site
Had metastatic site
|
102 Participants
n=108 Participants
|
21 Participants
n=25 Participants
|
10 Participants
n=10 Participants
|
133 Participants
n=143 Participants
|
|
Non-Liver Metastatic Site
Missing
|
1 Participants
n=108 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=143 Participants
|
|
Non-Liver Metastatic Site
Bone
|
28 Participants
n=108 Participants
|
1 Participants
n=25 Participants
|
2 Participants
n=10 Participants
|
31 Participants
n=143 Participants
|
|
Non-Liver Metastatic Site
Lung
|
74 Participants
n=108 Participants
|
9 Participants
n=25 Participants
|
2 Participants
n=10 Participants
|
85 Participants
n=143 Participants
|
|
Non-Liver Metastatic Site
Node
|
62 Participants
n=108 Participants
|
5 Participants
n=25 Participants
|
1 Participants
n=10 Participants
|
68 Participants
n=143 Participants
|
|
Non-Liver Metastatic Site
Other
|
41 Participants
n=108 Participants
|
6 Participants
n=25 Participants
|
2 Participants
n=10 Participants
|
49 Participants
n=143 Participants
|
|
Time from initial diagnosis to first dose day
|
12.75 months
n=108 Participants
|
16.49 months
n=25 Participants
|
22.11 months
n=10 Participants
|
15 months
n=143 Participants
|
|
Time from the most recent recurrence/progression to the first dose day
|
1.40 months
n=98 Participants • The date of most recent recurrence/progression is based on medical history which may not have been available for all patients.
|
1.31 months
n=23 Participants • The date of most recent recurrence/progression is based on medical history which may not have been available for all patients.
|
1.36 months
n=10 Participants • The date of most recent recurrence/progression is based on medical history which may not have been available for all patients.
|
1.36 months
n=131 Participants • The date of most recent recurrence/progression is based on medical history which may not have been available for all patients.
|
|
Histological Grade
Well differentiated
|
9 Participants
n=108 Participants
|
2 Participants
n=25 Participants
|
0 Participants
n=10 Participants
|
11 Participants
n=143 Participants
|
|
Histological Grade
Moderately differentiated
|
42 Participants
n=108 Participants
|
14 Participants
n=25 Participants
|
7 Participants
n=10 Participants
|
63 Participants
n=143 Participants
|
|
Histological Grade
Poorly differentiated
|
33 Participants
n=108 Participants
|
2 Participants
n=25 Participants
|
2 Participants
n=10 Participants
|
37 Participants
n=143 Participants
|
|
Histological Grade
Undifferentiated
|
1 Participants
n=108 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=143 Participants
|
|
Histological Grade
Unknown/missing
|
22 Participants
n=108 Participants
|
7 Participants
n=25 Participants
|
1 Participants
n=10 Participants
|
30 Participants
n=143 Participants
|
|
Histological Grade
Not Applicable
|
1 Participants
n=108 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=143 Participants
|
|
Stage at Time of Study Entry
Stage II
|
1 Participants
n=108 Participants
|
3 Participants
n=25 Participants
|
0 Participants
n=10 Participants
|
4 Participants
n=143 Participants
|
|
Stage at Time of Study Entry
Stage III
|
0 Participants
n=108 Participants
|
2 Participants
n=25 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=143 Participants
|
|
Stage at Time of Study Entry
Stage IV
|
107 Participants
n=108 Participants
|
20 Participants
n=25 Participants
|
10 Participants
n=10 Participants
|
137 Participants
n=143 Participants
|
PRIMARY outcome
Timeframe: Analysis was conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021.Population: Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib.
ORR is defined as the percentage (%) of subjects with a best overall response of Complete Response (CR) or Partial Response (PR), as per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1, evaluated by computed tomography (CT) or magnetic resonance imaging (MRI) scans every 28 days. RECIST (v1.1) response criteria were as follows: CR: disappearance of all target lesions. Any pathological lymph node (whether target or non-target) must have reduction in short axis to \<10 mm. PR: at least a 30% decrease from baseline in the sum of diameters of all target lesions. Note: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusions). Results were previously disclosed (22 June 2022). There are no additional efficacy endpoints to assess for Cohort 1, thus efficacy data were not re-analyzed for the final analysis. Due to early termination of the study, no formal efficacy analyses were performed for Cohorts 2 and 3.
Outcome measures
| Measure |
Cohort 1: FGFR2 Fusions
n=108 Participants
Infigratinib 125 mg once daily (3 wk on/1 wk off treatment)
|
|---|---|
|
Overall Response Rate (ORR) as Assessed by Blinded Independent Central Imaging Review (BICR)
|
23.1 Percentage (%) of subjects with CR or PR
Interval 15.6 to 32.2
|
SECONDARY outcome
Timeframe: Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff for the primary analysis was 01 March 2021.Population: Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib.
ORR is defined as the percentage (%) of subjects with a best overall response of CR or PR, evaluated by CT or MRI scans every 28 days. RECIST (v1.1) response criteria were as follows: CR: disappearance of all target lesions. Any pathological lymph node (whether target or non-target) must have reduction in short axis to \<10 mm. PR: at least a 30% decrease from baseline in the sum of diameters of all target lesions. Note: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusions) only. These results were previously disclosed (22 June 2022). There are no additional efficacy endpoints to assess for Cohort 1, thus efficacy data were not re-analyzed for the final analysis. Due to early termination of the study, no formal efficacy analyses were performed for Cohorts 2 and 3.
Outcome measures
| Measure |
Cohort 1: FGFR2 Fusions
n=108 Participants
Infigratinib 125 mg once daily (3 wk on/1 wk off treatment)
|
|---|---|
|
Overall Response Rate (ORR) as Assessed by the Investigator
|
32.4 Percentage (%) of subjects with CR or PR
Interval 23.7 to 42.1
|
SECONDARY outcome
Timeframe: Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021.Population: Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib.
BOR is defined as the best overall response a subject achieved during the study before any subsequent antineoplastic therapy. The endpoint is summarized for the rate of BOR of CR, PR, progressive disease (PD), and stable disease (SD), evaluated by CT or MRI scans every 28 days. RECIST (v1.1) response criteria were as follows: CR: disappearance of all target lesions. Any pathological lymph node (whether target or non-target) must have reduction in short axis to \<10 mm. PR: at least a 30% decrease from baseline in the sum of diameters of all target lesions. PD: at least a 20% increase in the sum of diameters of all target lesions from that of the smallest sum on study and an absolute increase in target lesion of at least 5mm. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study. Note: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusion)
Outcome measures
| Measure |
Cohort 1: FGFR2 Fusions
n=108 Participants
Infigratinib 125 mg once daily (3 wk on/1 wk off treatment)
|
|---|---|
|
Best Overall Response (BOR)
BOR by BICR · Confirmed CR
|
1 Participants
|
|
Best Overall Response (BOR)
BOR by BICR · Confirmed PR
|
24 Participants
|
|
Best Overall Response (BOR)
BOR by BICR · Stable Disease
|
66 Participants
|
|
Best Overall Response (BOR)
BOR by BICR · Progressive Disease
|
11 Participants
|
|
Best Overall Response (BOR)
BOR by BICR · Not Done
|
6 Participants
|
|
Best Overall Response (BOR)
BOR by Investigator · Confirmed CR
|
0 Participants
|
|
Best Overall Response (BOR)
BOR by Investigator · Confirmed PR
|
35 Participants
|
|
Best Overall Response (BOR)
BOR by Investigator · Stable Disease
|
56 Participants
|
|
Best Overall Response (BOR)
BOR by Investigator · Progressive Disease
|
11 Participants
|
|
Best Overall Response (BOR)
BOR by Investigator · Not Done
|
6 Participants
|
SECONDARY outcome
Timeframe: Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021.Population: Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib.
DCR is the percentage (%) of subjects with a BOR of CR, PR, or SD, evaluated by CT or MRI scans every 28 days. Results are based on both BICR and on Investigator assessment. RECIST (v1.1) response criteria were as follows: CR: disappearance of all target lesions. Any pathological lymph node (whether target or non-target) must have reduction in short axis to \<10 mm. PR: at least a 30% decrease from baseline in the sum of diameters of all target lesions. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study. Note: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusions) (disclosed 22 June 2022). There are no additional efficacy endpoints to assess for Cohort 1, thus efficacy data were not re-analyzed for the final analysis. Due to early termination of the study, no formal efficacy analyses were performed for Cohorts 2 and 3.
Outcome measures
| Measure |
Cohort 1: FGFR2 Fusions
n=108 Participants
Infigratinib 125 mg once daily (3 wk on/1 wk off treatment)
|
|---|---|
|
Disease Control Rate (DCR)
DCR by BICR
|
84.3 Percentage (%) with CR, PR, or SD
Interval 76.0 to 90.6
|
|
Disease Control Rate (DCR)
DCR by Investigator
|
84.3 Percentage (%) with CR, PR, or SD
Interval 76.0 to 90.6
|
SECONDARY outcome
Timeframe: Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021.Population: Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib.
PFS was calculated as the number of months from the first dose of study drug to the first documented progression or death due to any cause, whichever occurred earlier. Subjects without an assessment of progression or death were censored at the last adequate tumor assessment. For subjects who had an event after ≥2 missed visits, the subject was censored at the last adequate tumor assessment before the missing visit. Disease progression was assessed per RECIST (v1.1) and defined as at least a 20% increase in the sum of diameters of all target lesions from that of the smallest sum on study and an absolute increase in target lesion of at least 5mm. Results are based on both BICR and on Investigator assessment. Note: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusions) (disclosed 22 June 2022). Due to early termination of the study, no formal efficacy analyses were performed for Cohorts 2 and 3.
Outcome measures
| Measure |
Cohort 1: FGFR2 Fusions
n=108 Participants
Infigratinib 125 mg once daily (3 wk on/1 wk off treatment)
|
|---|---|
|
Progression-Free Survival (PFS)
PFS by BICR
|
7.29 months
Interval 5.59 to 7.56
|
|
Progression-Free Survival (PFS)
PFS by Investigator
|
6.74 months
Interval 5.55 to 7.56
|
SECONDARY outcome
Timeframe: Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021.Population: Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib.
OS was defined as the time (months) from the date of start of treatment to the date of death due to any cause. Note: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusions) (disclosed 22 June 2022). Due to early termination of the study, no formal efficacy analyses were performed for Cohorts 2 and 3.
Outcome measures
| Measure |
Cohort 1: FGFR2 Fusions
n=108 Participants
Infigratinib 125 mg once daily (3 wk on/1 wk off treatment)
|
|---|---|
|
Overall Survival (OS)
|
11.86 months
Interval 10.68 to 14.85
|
SECONDARY outcome
Timeframe: Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021.Population: Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib. Conducted in a subgroup of subjects who were confirmed responders (CR or PR) as assessed by BICR (N = 25) or by the Investigator (N = 35).
DOR is defined as the time (months) from the initial response to the time of the event; defined as the first documented progression or death due to any cause, whichever was earlier. Note that results are based on a subgroup of subjects with confirmed responses (CR or PR) as assessed by BICR or by the Investigator. RECIST (v1.1) response criteria was as follows: CR: disappearance of all target lesions. Any pathological lymph node (whether target or non-target) must have reduction in short axis to \<10 mm. PR: at least a 30% decrease from baseline in the sum of diameters of all target lesions. Note: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusions) (disclosed 22 June 2022). Due to early termination of the study, no formal efficacy analyses were performed for Cohorts 2 and 3.
Outcome measures
| Measure |
Cohort 1: FGFR2 Fusions
n=35 Participants
Infigratinib 125 mg once daily (3 wk on/1 wk off treatment)
|
|---|---|
|
Duration of Response (DOR)
DOR by BICR
|
5.55 months
Interval 3.78 to 7.66
|
|
Duration of Response (DOR)
DOR by Investigator
|
7.23 months
Interval 5.16 to 9.0
|
SECONDARY outcome
Timeframe: Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021.Population: Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib. Conducted in a subgroup of subjects who were confirmed responders (CR or PR) as assessed by BICR (N = 25) or by the Investigator (N = 35).
Response onset was defined as the time (months) from the first study treatment administration date to the initial response. Note that results are based on a subgroup of subjects with confirmed responses (CR or PR) as assessed by BICR or by the Investigator. RECIST (v1.1) response criteria was as follows: CR: disappearance of all target lesions. Any pathological lymph node (whether target or non-target) must have reduction in short axis to \<10 mm. PR: at least a 30% decrease from baseline in the sum of diameters of all target lesions. Note: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusions) (disclosed 22 June 2022). Due to early termination of the study, no formal efficacy analyses were performed for Cohorts 2 and 3.
Outcome measures
| Measure |
Cohort 1: FGFR2 Fusions
n=35 Participants
Infigratinib 125 mg once daily (3 wk on/1 wk off treatment)
|
|---|---|
|
Response Onset
Response onset by BICR
|
3.61 months
Interval 1.38 to 7.36
|
|
Response Onset
Response onset by Investigator
|
1.94 months
Interval 1.38 to 18.76
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021.Population: Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib. Conducted in a subgroup of subjects with both a PFS measure while on infigratinib and available TTP for their last prior line of therapy (N = 103).
The GMI is defined as the ratio of PFS (months) during treatment with infigratinib relative to the time (months) to progression (TTP) during treatment with last prior line of therapy. Subjects served as their own control. Results are provided for both BICR and Investigator assessment. Note: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusions) (disclosed 22 June 2022). Due to early termination of the study, no formal efficacy analyses were performed for Cohorts 2 and 3.
Outcome measures
| Measure |
Cohort 1: FGFR2 Fusions
n=103 Participants
Infigratinib 125 mg once daily (3 wk on/1 wk off treatment)
|
|---|---|
|
Growth Modulation Index (GMI)
PFS by BICR
|
1.22 Ratio (PFS/TTP) in Months
Interval 0.0 to 120.0
|
|
Growth Modulation Index (GMI)
PFS by Investigator
|
1.24 Ratio (PFS/TTP) in Months
Interval 0.0 to 120.0
|
POST_HOC outcome
Timeframe: Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021.Population: Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib Conducted in a subgroup of subjects who were receiving infigratinib as a third or later line of treatment (N = 59).
Post-hoc subgroup assessment of efficacy in those subjects who were receiving infigratinib as a third or later line of treatment. Investigator-assessed ORR was obtained from subjects' medical histories to provide a baseline evaluation of their response after historical second-line antineoplastic treatment prior to infigratinib treatment. Investigator-assessed ORR was then calculated in the same subjects after third- or later-line infigratinib therapy. ORR is defined as the percentage (%) of patients with CR or PR, per RECIST (v1.1). RECIST (v1.1) response criteria were as follows: CR: disappearance of all target lesions. Any pathological lymph node (whether target or non-target) must have reduction in short axis to \<10 mm. PR: at least a 30% decrease from baseline in the sum of diameters of all target lesions. Note: The primary efficacy outcome measures were prespecified only for Cohort 1 (22 June 2022). No formal efficacy analyses were performed for Cohorts 2 and 3.
Outcome measures
| Measure |
Cohort 1: FGFR2 Fusions
n=59 Participants
Infigratinib 125 mg once daily (3 wk on/1 wk off treatment)
|
|---|---|
|
Retrospective Analysis of Post-second-line Antineoplastic Treatment Outcomes on ORR
After Second-Line Therapy (Prior to Infigratinib Treatment)
|
0 Percentage (%) of patients with CR or PR
Interval 0.0 to 6.1
|
|
Retrospective Analysis of Post-second-line Antineoplastic Treatment Outcomes on ORR
Third or Later-Line Therapy (Infigratinib)
|
28.8 Percentage (%) of patients with CR or PR
Interval 17.8 to 42.1
|
POST_HOC outcome
Timeframe: Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021.Population: Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib. Conducted in a subgroup of subjects who were receiving infigratinib as a third or later line of treatment (N=59).
Post-hoc subgroup assessment of efficacy in those subjects who were receiving infigratinib as a third or later line of treatment. Investigator-assessed PFS was obtained from subjects' medical histories to provide a baseline evaluation of their response after historical second-line antineoplastic treatment prior to infigratinib treatment. Investigator-assessed PFS was then calculated in the same subjects after third- or later-line infigratinib therapy. Note: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusions) (disclosed 22 June 2022). Due to early termination of the study, no formal efficacy analyses were performed for Cohorts 2 and 3.
Outcome measures
| Measure |
Cohort 1: FGFR2 Fusions
n=59 Participants
Infigratinib 125 mg once daily (3 wk on/1 wk off treatment)
|
|---|---|
|
Retrospective Analysis of Post-second-line Antineoplastic Treatment Outcomes on PFS
After Second-Line Therapy (Prior to Infigratinib Treatment)
|
5.36 months
Interval 3.25 to 8.15
|
|
Retrospective Analysis of Post-second-line Antineoplastic Treatment Outcomes on PFS
Third or Later-Line Therapy (Infigratinib)
|
6.93 months
Interval 4.76 to 7.59
|
POST_HOC outcome
Timeframe: Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021.Population: Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib Conducted in a subgroup of subjects who were receiving infigratinib as a third or later line of treatment (N=59).
Post-hoc subgroup assessment of efficacy in those subjects who were receiving infigratinib as a third or later line of treatment. Investigator-assessed BOR was obtained from subjects' medical histories to provide a baseline evaluation of their response after historical second-line antineoplastic treatment prior to infigratinib treatment. Investigator-assessed BOR was then calculated in the same subjects after third- or later-line infigratinib therapy. The endpoint is summarized for the rate of BOR of PD, SD, PR, and CR. Note: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusions) (disclosed 22 June 2022). Due to early termination of the study, no formal efficacy analyses were performed for Cohorts 2 and 3.
Outcome measures
| Measure |
Cohort 1: FGFR2 Fusions
n=59 Participants
Infigratinib 125 mg once daily (3 wk on/1 wk off treatment)
|
|---|---|
|
Retrospective Analysis of Post-second-line Antineoplastic Treatment Outcomes on BOR
After Second-Line Therapy (Prior to Infigratinib Treatment) · Complete response
|
0 Participants
|
|
Retrospective Analysis of Post-second-line Antineoplastic Treatment Outcomes on BOR
After Second-Line Therapy (Prior to Infigratinib Treatment) · Partial response
|
0 Participants
|
|
Retrospective Analysis of Post-second-line Antineoplastic Treatment Outcomes on BOR
After Second-Line Therapy (Prior to Infigratinib Treatment) · Stable disease
|
19 Participants
|
|
Retrospective Analysis of Post-second-line Antineoplastic Treatment Outcomes on BOR
After Second-Line Therapy (Prior to Infigratinib Treatment) · Progressive disease
|
22 Participants
|
|
Retrospective Analysis of Post-second-line Antineoplastic Treatment Outcomes on BOR
After Second-Line Therapy (Prior to Infigratinib Treatment) · Unknown
|
18 Participants
|
|
Retrospective Analysis of Post-second-line Antineoplastic Treatment Outcomes on BOR
After Second-Line Therapy (Prior to Infigratinib Treatment) · Not done
|
0 Participants
|
|
Retrospective Analysis of Post-second-line Antineoplastic Treatment Outcomes on BOR
Third or Later-Line Therapy (Infigratinib) · Complete response
|
0 Participants
|
|
Retrospective Analysis of Post-second-line Antineoplastic Treatment Outcomes on BOR
Third or Later-Line Therapy (Infigratinib) · Partial response
|
17 Participants
|
|
Retrospective Analysis of Post-second-line Antineoplastic Treatment Outcomes on BOR
Third or Later-Line Therapy (Infigratinib) · Stable disease
|
31 Participants
|
|
Retrospective Analysis of Post-second-line Antineoplastic Treatment Outcomes on BOR
Third or Later-Line Therapy (Infigratinib) · Progressive disease
|
7 Participants
|
|
Retrospective Analysis of Post-second-line Antineoplastic Treatment Outcomes on BOR
Third or Later-Line Therapy (Infigratinib) · Unknown
|
0 Participants
|
|
Retrospective Analysis of Post-second-line Antineoplastic Treatment Outcomes on BOR
Third or Later-Line Therapy (Infigratinib) · Not done
|
4 Participants
|
Adverse Events
Cohort 1: FGFR2 Fusions
Serious events: 35 serious events
Other events: 107 other events
Deaths: 93 deaths
Cohort 2: Other FGFR Genetic Alterations
Serious events: 11 serious events
Other events: 25 other events
Deaths: 19 deaths
Cohort 3: FGFR2 Fusions and Prior FGFR Inhibitor
Serious events: 2 serious events
Other events: 10 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Cohort 1: FGFR2 Fusions
n=108 participants at risk
Infigratinib 125 mg once daily (3 wk on/1 wk off treatment)
|
Cohort 2: Other FGFR Genetic Alterations
n=25 participants at risk
Infigratinib 125 mg once daily (3 wk on/1 wk off treatment)
|
Cohort 3: FGFR2 Fusions and Prior FGFR Inhibitor
n=10 participants at risk
Infigratinib 125 mg once daily (3 wk on/1 wk off treatment)
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.7%
4/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Cardiac disorders
Atrial fibrillation
|
0.93%
1/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Cardiac disorders
Tachycardia
|
0.93%
1/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Endocrine disorders
Hypothyroidism
|
0.93%
1/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.9%
2/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
4.0%
1/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.9%
2/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Gastrointestinal disorders
Ascites
|
1.9%
2/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
10.0%
1/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Gastrointestinal disorders
Constipation
|
1.9%
2/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.93%
1/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.93%
1/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.93%
1/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
4.0%
1/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Gastrointestinal disorders
Noninfective sialoadenitis
|
0.93%
1/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.93%
1/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.93%
1/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Gastrointestinal disorders
Stomatitis
|
0.93%
1/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
4.0%
1/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
General disorders
Pyrexia
|
3.7%
4/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
8.0%
2/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
General disorders
Asthenia
|
0.93%
1/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
General disorders
Gait disturbance
|
0.93%
1/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
General disorders
General physical health deterioration
|
0.93%
1/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
4.0%
1/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
General disorders
Non-cardiac chest pain
|
0.93%
1/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Hepatobiliary disorders
Cholangitis
|
1.9%
2/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.93%
1/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.93%
1/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Infections and infestations
Sepsis
|
2.8%
3/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
4.0%
1/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Infections and infestations
Cellulitis
|
1.9%
2/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Infections and infestations
Infection
|
1.9%
2/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Infections and infestations
Bacteraemia
|
0.93%
1/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Infections and infestations
Biliary abscess
|
0.93%
1/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.93%
1/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Infections and infestations
Febrile infection
|
0.93%
1/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Infections and infestations
Intervertebral discitis
|
0.93%
1/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Infections and infestations
Lung infection
|
0.93%
1/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Infections and infestations
Peritonitis bacterial
|
0.93%
1/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Infections and infestations
Pneumonia
|
0.93%
1/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Infections and infestations
Urinary tract infection
|
0.93%
1/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Infections and infestations
Influenza
|
0.00%
0/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
4.0%
1/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Injury, poisoning and procedural complications
Stress fracture
|
0.93%
1/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
4.0%
1/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
4.0%
1/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
3.7%
4/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
1.9%
2/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
10.0%
1/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Metabolism and nutrition disorders
Calciphylaxis
|
0.93%
1/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.93%
1/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.93%
1/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.93%
1/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
4.0%
1/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.93%
1/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.93%
1/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.93%
1/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
4.0%
1/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
4.0%
1/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
4.0%
1/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.93%
1/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.93%
1/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Nervous system disorders
Ischaemic stroke
|
0.93%
1/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.9%
2/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Renal and urinary disorders
Urinary retention
|
0.93%
1/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.93%
1/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
4.0%
1/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.93%
1/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
4.0%
1/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.93%
1/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Vascular disorders
Hypotension
|
0.93%
1/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
4.0%
1/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
10.0%
1/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
10.0%
1/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
10.0%
1/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Product Issues
Device occlusion
|
0.93%
1/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
Other adverse events
| Measure |
Cohort 1: FGFR2 Fusions
n=108 participants at risk
Infigratinib 125 mg once daily (3 wk on/1 wk off treatment)
|
Cohort 2: Other FGFR Genetic Alterations
n=25 participants at risk
Infigratinib 125 mg once daily (3 wk on/1 wk off treatment)
|
Cohort 3: FGFR2 Fusions and Prior FGFR Inhibitor
n=10 participants at risk
Infigratinib 125 mg once daily (3 wk on/1 wk off treatment)
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
18.5%
20/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
20.0%
5/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
8.3%
9/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
8.0%
2/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
6.5%
7/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
4.0%
1/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.5%
7/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Eye disorders
Dry eye
|
36.1%
39/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
12.0%
3/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
40.0%
4/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Eye disorders
Vision blurred
|
21.3%
23/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
16.0%
4/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
10.0%
1/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Eye disorders
Lacrimation increased
|
12.0%
13/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
8.0%
2/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Eye disorders
Trichiasis
|
12.0%
13/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
16.0%
4/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Eye disorders
Blepharitis
|
11.1%
12/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
8.0%
2/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Eye disorders
Chorioretinopathy
|
9.3%
10/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
10.0%
1/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Eye disorders
Punctate keratitis
|
9.3%
10/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
8.0%
2/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Eye disorders
Cataract nuclear
|
7.4%
8/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
10.0%
1/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Eye disorders
Growth of eyelashes
|
6.5%
7/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Eye disorders
Keratitis
|
6.5%
7/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
8.0%
2/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Eye disorders
Ocular hyperaemia
|
5.6%
6/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
8.0%
2/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Eye disorders
Subretinal fluid
|
5.6%
6/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
8.0%
2/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
4.0%
1/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
10.0%
1/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Gastrointestinal disorders
Stomatitis
|
54.6%
59/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
52.0%
13/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
70.0%
7/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Gastrointestinal disorders
Constipation
|
31.5%
34/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
44.0%
11/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
30.0%
3/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Gastrointestinal disorders
Dry mouth
|
25.9%
28/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
28.0%
7/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
10.0%
1/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
27/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
32.0%
8/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
30.0%
3/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Gastrointestinal disorders
Vomiting
|
23.1%
25/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
20.0%
5/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
30.0%
3/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Gastrointestinal disorders
Nausea
|
19.4%
21/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
40.0%
10/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
30.0%
3/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Gastrointestinal disorders
Dyspepsia
|
18.5%
20/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
12.0%
3/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Gastrointestinal disorders
Abdominal pain
|
17.6%
19/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
8.0%
2/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
10.0%
1/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
14.8%
16/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
16.0%
4/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Gastrointestinal disorders
Dysphagia
|
6.5%
7/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
8.0%
2/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.6%
6/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
4.0%
1/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
10.0%
1/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Gastrointestinal disorders
Oral pain
|
5.6%
6/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
8.0%
2/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
8.0%
2/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
0.00%
0/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
8.0%
2/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
General disorders
Fatigue
|
40.7%
44/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
40.0%
10/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
30.0%
3/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
General disorders
Pyrexia
|
15.7%
17/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
12.0%
3/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
10.0%
1/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
General disorders
Oedema peripheral
|
13.9%
15/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
12.0%
3/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
10.0%
1/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
General disorders
Chills
|
7.4%
8/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
4.0%
1/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
General disorders
Asthenia
|
5.6%
6/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
4.0%
1/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
General disorders
Non-cardiac chest pain
|
5.6%
6/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Infections and infestations
Paronychia
|
10.2%
11/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
8.0%
2/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Infections and infestations
Urinary tract infection
|
9.3%
10/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
12.0%
3/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
10.0%
1/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
4.0%
1/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
10.0%
1/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Investigations
Blood creatinine increased
|
25.0%
27/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
32.0%
8/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
10.0%
1/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Investigations
Aspartate aminotransferase increased
|
23.1%
25/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
28.0%
7/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
18/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
16.0%
4/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Investigations
Blood alkaline phosphatase increased
|
15.7%
17/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
8.0%
2/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Investigations
Weight decreased
|
15.7%
17/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
20.0%
5/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Investigations
Lipase increased
|
12.0%
13/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
16.0%
4/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Investigations
Blood bilirubin increased
|
8.3%
9/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
10.0%
1/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Investigations
Amylase increased
|
6.5%
7/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
4.0%
1/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.93%
1/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
8.0%
2/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Investigations
Platelet count decreased
|
0.00%
0/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
8.0%
2/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
76.9%
83/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
92.0%
23/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
70.0%
7/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
26.9%
29/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
20.0%
5/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
10.0%
1/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
24.1%
26/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
28.0%
7/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
30.0%
3/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
23.1%
25/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
20.0%
5/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
20.0%
2/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
13.0%
14/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
8.0%
2/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
10.0%
1/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
8.3%
9/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
4.0%
1/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
8.3%
9/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
8.0%
2/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
7.4%
8/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.4%
8/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
8.0%
2/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.5%
7/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
8.0%
2/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
6.5%
7/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
4.0%
1/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
8.0%
2/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
32.4%
35/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
16.0%
4/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
10.0%
1/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
15.7%
17/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
20.0%
5/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
10.0%
1/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.8%
16/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
8.0%
2/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
10.0%
1/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.0%
14/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
16.0%
4/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
6.5%
7/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
20.0%
2/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.5%
7/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
8.0%
2/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.00%
0/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
4.0%
1/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
10.0%
1/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
8.0%
2/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Nervous system disorders
Dysgeusia
|
31.5%
34/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
24.0%
6/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Nervous system disorders
Headache
|
17.6%
19/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
16.0%
4/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
30.0%
3/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Nervous system disorders
Dizziness
|
9.3%
10/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
12.0%
3/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Nervous system disorders
Memory impairment
|
5.6%
6/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.6%
6/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Psychiatric disorders
Insomnia
|
13.0%
14/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
20.0%
2/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
17.6%
19/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
20.0%
5/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
60.0%
6/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.0%
14/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
16.0%
4/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
10.0%
1/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.3%
10/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
8.0%
2/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
10.0%
1/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.3%
9/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
8.0%
2/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.93%
1/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
12.0%
3/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
12.0%
3/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
39.8%
43/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
36.0%
9/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
10.0%
1/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
34.3%
37/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
24.0%
6/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
50.0%
5/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
24.1%
26/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
16.0%
4/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
30.0%
3/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
18.5%
20/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
16.0%
4/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
20.0%
2/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
17.6%
19/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
8.0%
2/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
15.7%
17/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
12.0%
3/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Skin and subcutaneous tissue disorders
Onychalgia
|
13.0%
14/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
4.0%
1/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
13.0%
14/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
16.0%
4/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
20.0%
2/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
7.4%
8/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
10.0%
1/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.4%
8/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.5%
7/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
20.0%
2/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.6%
6/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
8.0%
2/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
8.0%
2/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
4.0%
1/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
10.0%
1/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Vascular disorders
Hypotension
|
0.00%
0/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
12.0%
3/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Eye disorders
Cataract
|
0.00%
0/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
4.0%
1/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
10.0%
1/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Eye disorders
Eye pain
|
0.00%
0/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
8.0%
2/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
10.0%
1/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Eye disorders
Keratopathy
|
0.00%
0/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
10.0%
1/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Eye disorders
Retinal drusen
|
0.00%
0/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
10.0%
1/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Eye disorders
Trichomegaly
|
0.00%
0/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
8.0%
2/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Eye disorders
vitreous detachment
|
0.00%
0/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
10.0%
1/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
10.0%
1/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
10.0%
1/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
10.0%
1/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
10.0%
1/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
10.0%
1/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Infections and infestations
Infection
|
0.00%
0/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
10.0%
1/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
10.0%
1/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
10.0%
1/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Investigations
Creatinine renal clearance decreased
|
0.00%
0/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
10.0%
1/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
10.0%
1/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
10.0%
1/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
10.0%
1/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
10.0%
1/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
10.0%
1/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/108 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
0.00%
0/25 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
10.0%
1/10 • From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0. Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
|
Additional Information
David van Veenhuyzen, Vice President, Clinical Development
QED Therapeutics, Inc.
Phone: 1 650 391-9740
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place