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An Efficacy and Safety Study of Erdafitinib (JNJ-42756493) in Participants With Urothelial Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02365597
Recruitment Status : Active, not recruiting
First Posted : February 19, 2015
Results First Posted : October 10, 2023
Last Update Posted : May 7, 2024
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Urothelial Cancer
Interventions Drug: Erdafitinib
Drug: Midazolam
Drug: Metformin
Enrollment 239
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg Drug-Drug Interaction (DDI) Sub-study: Midazolam 2.5 mg + Metformin 1000 mg + Erdafitinib 8/9 mg
Hide Arm/Group Description Participants received single dose of erdafitinib 10 mg tablet, orally, once daily, starting from Day 1 through Day 7 and from Day 15 through Day 21 and so on, that is 7-day on and off in each subsequent 28-day cycles starting from Cycle 1. Based on serum phosphate (PO4) levels, there was an option to up-titrate erdafitinib dose to 12 mg, orally, once daily starting from Cycle 2 Day 1 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation. Participants received single dose of erdafitinib 6 mg tablet, orally, once daily, starting from Day 1 through Day 28 in each subsequent 28-day cycles starting from Cycle 1. Based on serum PO4 levels, there was an option to up-titrate erdafitinib dose to 8 mg, orally, once daily starting from Cycle 2 Day 1 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation. Participants received single dose of erdafitinib 8 mg tablet, orally, once daily, starting from Day 1 through Day 28 in each subsequent 28-day cycles starting from Cycle 1. Based on serum PO4 levels, there was an option to up-titrate erdafitinib dose to 9 mg, orally, once daily starting from Cycle 1 Day 15 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation. Participants received pretreatment with single doses of midazolam 2.5 mg syrup orally on Day -2 and metformin 1000 mg tablet orally on Day -1 along with erdafitinib 8 mg tablet, orally, on 28-day cycles starting from Cycle 1 Day 1 to Day 15 (or up-titrated to 9 mg on Day 15 based on Day 14 serum PO4 levels) until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.
Period Title: Overall Study
Started 33 79 102 25
Treated (Safety Analysis Set) 33 78 101 25
Completed 31 62 83 6
Not Completed 2 17 19 19
Reason Not Completed
Lost to Follow-up             0             1             0             1
Withdrawal by Subject             1             8             5             1
Sponsor's decision             1             3             13             0
Other             0             4             0             0
Enrolled but not treated             0             1             1             0
Ongoing             0             0             0             17
Arm/Group Title Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg Drug-Drug Interaction (DDI) Sub-study: Midazolam 2.5 mg + Metformin 1000 mg + Erdafitinib 8/9 mg Total
Hide Arm/Group Description Participants received single dose of erdafitinib 10 mg tablet, orally, once daily, starting from Day 1 through Day 7 and from Day 15 through Day 21 and so on, that is 7-day on and off in each subsequent 28-day cycles starting from Cycle 1. Based on serum phosphate (PO4) levels, there was an option to up-titrate erdafitinib dose to 12 mg, orally, once daily starting from Cycle 2 Day 1 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation. Participants received single dose of erdafitinib 6 mg tablet, orally, once daily, starting from Day 1 through Day 28 in each subsequent 28-day cycles starting from Cycle 1. Based on serum PO4 levels, there was an option to up-titrate erdafitinib dose to 8 mg, orally, once daily starting from Cycle 2 Day 1 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation. Participants received single dose of erdafitinib 8 mg tablet, orally, once daily, starting from Day 1 through Day 28 in each subsequent 28-day cycles starting from Cycle 1. Based on serum PO4 levels, there was an option to up-titrate erdafitinib dose to 9 mg, orally, once daily starting from Cycle 1 Day 15 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation. Participants received pretreatment with single doses of midazolam 2.5 mg syrup orally on Day -2 and metformin 1000 mg tablet orally on Day -1 along with erdafitinib 8 mg tablet, orally, on 28-day cycles starting from Cycle 1 Day 1 to Day 15 (or up-titrated to 9 mg on Day 15 based on Day 14 serum PO4 levels) until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation. Total of all reporting groups
Overall Number of Baseline Participants 33 78 101 25 237
Hide Baseline Analysis Population Description
Safety analysis set included participants who received at least 1 dose of study drug.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 78 participants 101 participants 25 participants 237 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
11
  33.3%
39
  50.0%
39
  38.6%
11
  44.0%
100
  42.2%
>=65 years
22
  66.7%
39
  50.0%
62
  61.4%
14
  56.0%
137
  57.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants 78 participants 101 participants 25 participants 237 participants
68.6  (7.98) 64.5  (10.36) 66.1  (10.2) 64.8  (10.35) 65.8  (10.03)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 78 participants 101 participants 25 participants 237 participants
Female
11
  33.3%
24
  30.8%
24
  23.8%
10
  40.0%
69
  29.1%
Male
22
  66.7%
54
  69.2%
77
  76.2%
15
  60.0%
168
  70.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 78 participants 101 participants 25 participants 237 participants
Hispanic or Latino
1
   3.0%
2
   2.6%
2
   2.0%
1
   4.0%
6
   2.5%
Not Hispanic or Latino
25
  75.8%
68
  87.2%
75
  74.3%
22
  88.0%
190
  80.2%
Unknown or Not Reported
7
  21.2%
8
  10.3%
24
  23.8%
2
   8.0%
41
  17.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 33 participants 78 participants 101 participants 25 participants 237 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   6.1%
11
  14.1%
5
   5.0%
0
   0.0%
18
   7.6%
Black or African American
0
   0.0%
2
   2.6%
2
   2.0%
0
   0.0%
4
   1.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
24
  72.7%
56
  71.8%
75
  74.3%
20
  80.0%
175
  73.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
3
  12.0%
3
   1.3%
Unknown or Not Reported
7
  21.2%
7
   9.0%
18
  17.8%
2
   8.0%
34
  14.3%
Other
0
   0.0%
2
   2.6%
1
   1.0%
0
   0.0%
3
   1.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 33 participants 78 participants 101 participants 25 participants 237 participants
AUSTRIA
0
   0.0%
2
   2.6%
2
   2.0%
0
   0.0%
4
   1.7%
BELGIUM
3
   9.1%
2
   2.6%
4
   4.0%
0
   0.0%
9
   3.8%
FRANCE
7
  21.2%
9
  11.5%
20
  19.8%
1
   4.0%
37
  15.6%
GERMANY
0
   0.0%
5
   6.4%
6
   5.9%
0
   0.0%
11
   4.6%
INDIA
0
   0.0%
0
   0.0%
0
   0.0%
3
  12.0%
3
   1.3%
ISRAEL
0
   0.0%
2
   2.6%
3
   3.0%
0
   0.0%
5
   2.1%
ITALY
4
  12.1%
12
  15.4%
19
  18.8%
0
   0.0%
35
  14.8%
MOLDOVA, REPUBLIC OF
0
   0.0%
1
   1.3%
0
   0.0%
0
   0.0%
1
   0.4%
ROMANIA
0
   0.0%
1
   1.3%
1
   1.0%
0
   0.0%
2
   0.8%
RUSSIAN FEDERATION
1
   3.0%
7
   9.0%
11
  10.9%
0
   0.0%
19
   8.0%
SOUTH KOREA
2
   6.1%
9
  11.5%
3
   3.0%
0
   0.0%
14
   5.9%
SPAIN
7
  21.2%
8
  10.3%
4
   4.0%
20
  80.0%
39
  16.5%
TAIWAN
0
   0.0%
2
   2.6%
2
   2.0%
0
   0.0%
4
   1.7%
TURKEY
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.0%
1
   0.4%
UNITED KINGDOM
1
   3.0%
5
   6.4%
5
   5.0%
0
   0.0%
11
   4.6%
UNITED STATES
8
  24.2%
13
  16.7%
21
  20.8%
0
   0.0%
42
  17.7%
1.Primary Outcome
Title Main Study: Percentage of Participants With Best (Overall) Objective Response
Hide Description Percentage of participants with best (overall) objective response were reported. Best objective response is defined as the best (overall) objective response a participants achieved during the study in the order of complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), where CR and PR were confirmed as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. As per RECIST version 1.1, CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must had reduction in the short axis to less than (<) 10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Responders are participants with BOR of CR or PR.
Time Frame From Cycle 1 Day 1 up to 6 years 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
The population included participants who received at least 1 dose of study drug.
Arm/Group Title Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg
Hide Arm/Group Description:
Participants received single dose of erdafitinib 10 mg tablet, orally, once daily, starting from Day 1 through Day 7 and from Day 15 through Day 21 and so on, that is 7-day on and off in each subsequent 28-day cycles starting from Cycle 1. Based on serum phosphate (PO4) levels, there was an option to up-titrate erdafitinib dose to 12 mg, orally, once daily starting from Cycle 2 Day 1 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.
Participants received single dose of erdafitinib 6 mg tablet, orally, once daily, starting from Day 1 through Day 28 in each subsequent 28-day cycles starting from Cycle 1. Based on serum PO4 levels, there was an option to up-titrate erdafitinib dose to 8 mg, orally, once daily starting from Cycle 2 Day 1 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.
Participants received single dose of erdafitinib 8 mg tablet, orally, once daily, starting from Day 1 through Day 28 in each subsequent 28-day cycles starting from Cycle 1. Based on serum PO4 levels, there was an option to up-titrate erdafitinib dose to 9 mg, orally, once daily starting from Cycle 1 Day 15 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.
Overall Number of Participants Analyzed 33 78 101
Measure Type: Number
Unit of Measure: Percentage of Participants
21.2 34.6 39.6
2.Primary Outcome
Title Drug-Drug Interaction (DDI) Substudy: Maximum Observed Plasma Concentration (Cmax) of Midazolam Alone or in Combination With Erdafitinib
Hide Description Cmax is the maximum observed plasma concentration of midazolam alone or in combination with erdafitinib.
Time Frame Cycle 1 Day -2 (predose) up to Day 13 post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least 1 sample collected during treatment to determine the drug concentration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
Arm/Group Title DDI Study: Midazolam 2.5 mg Alone DDI Study: Midazolam 2.5 mg + Erdafitinib 8 mg
Hide Arm/Group Description:
Participants received single dose of pretreatment midazolam 2.5 mg syrup, orally, once daily, starting from Day -2 through Day 13 of Cycle 1 (each cycle length=28 days).
Participants received single dose of pretreatment midazolam 2.5 mg syrup, orally, once daily, starting from Day -2 through Day 13 of Cycle 1 along with erdafitinib 8 mg starting from Day 1 up to Day 15 of Cycle 1 (each cycle length=28 days).
Overall Number of Participants Analyzed 23 22
Mean (Standard Deviation)
Unit of Measure: nanograms per milliliter (ng/mL)
18.4  (7.32) 15.4  (5.90)
3.Primary Outcome
Title Drug-Drug Interaction (DDI) Substudy: Maximum Observed Plasma Concentration (Cmax) of 1-OH-Midazolam (Midazolam Metabolite) Alone or in Combination With Erdafitinib
Hide Description Cmax is the maximum observed plasma concentration of 1-OH-Midazolam (midazolam metabolite) alone or in combination with erdafitinib.
Time Frame Cycle 1 Day -2 (predose) up to Day 13 post dose (each cycle length=28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least 1 sample collected during treatment to determine the drug concentration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
Arm/Group Title DDI Study: 1-OH-Midazolam 2.5 mg Alone DDI Study: 1-OH-Midazolam 2.5 mg + Erdafitinib 8 mg
Hide Arm/Group Description:
Participants received single dose of pretreatment 1-OH-Midazolam 2.5 mg syrup, orally, once daily, starting from Day -2 through Day 13 of Cycle 1 (each cycle length=28 days).
Participants received single dose of pretreatment 1-OH-Midazolam 2.5 mg syrup, orally, once daily, starting from Day -2 through Day 13 of Cycle 1 along with erdafitinib 8 mg starting from Day 1 up to Day 15 of Cycle 1 (each cycle length=28 days).
Overall Number of Participants Analyzed 23 22
Mean (Standard Deviation)
Unit of Measure: ng/mL
5.39  (3.42) 4.82  (2.60)
4.Primary Outcome
Title Drug-Drug Interaction (DDI) Substudy: Maximum Observed Plasma Concentration (Cmax) of Metformin Alone or in Combination With Erdafitinib
Hide Description Cmax is the maximum observed plasma concentration of metformin alone or in combination with erdafitinib
Time Frame Cycle 1 Day -1 (predose) up to Day 14 post dose (each cycle length=28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least 1 sample collected during treatment to determine the drug concentration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
Arm/Group Title DDI Study: Metformin 1000 mg Alone DDI Study: Metformin 1000 mg + Erdafitinib 8 mg
Hide Arm/Group Description:
Participants received single dose of metformin 1000 mg tablet, orally, once daily, starting from Day -1 through Day 14 of Cycle 1 (each cycle length=28 days).
Participants received single dose of metformin 1000 mg tablet, orally, once daily, starting from Day -1 through Day 14 of Cycle 1 along with erdafitinib 8 mg starting from Day 1 up to Day 15 of Cycle 1 (each cycle length=28 days).
Overall Number of Participants Analyzed 20 19
Mean (Standard Deviation)
Unit of Measure: ng/mL
2465  (986) 2687  (1127)
5.Primary Outcome
Title Drug-Drug Interaction (DDI) Substudy: Time to Reach the Maximum Observed Plasma Concentration (Tmax) of Midazolam Alone or in Combination With Erdafitinib
Hide Description Tmax is the time to reach the maximum observed plasma concentration of midazolam alone or in combination with erdafitinib.
Time Frame Cycle 1 Day -2 (predose) up to Day 13 post dose (each cycle length=28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least 1 sample collected during treatment to determine the drug concentration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
Arm/Group Title DDI Study: Midazolam 2.5 mg Alone DDI Study: Midazolam 2.5 mg + Erdafitinib 8 mg
Hide Arm/Group Description:
Participants received single dose of pretreatment midazolam 2.5 mg syrup, orally, once daily, starting from Day -2 through Day 13 of Cycle 1 (each cycle length=28 days).
Participants received single dose of pretreatment midazolam 2.5 mg syrup, orally, once daily, starting from Day -2 through Day 13 of Cycle 1 along with erdafitinib 8 mg starting from Day 1 up to Day 15 of Cycle 1 (each cycle length=28 days).
Overall Number of Participants Analyzed 23 22
Median (Full Range)
Unit of Measure: Hours
0.50
(0.47 to 1.08)
0.58
(0.45 to 2.00)
6.Primary Outcome
Title Drug-Drug Interaction (DDI) Substudy: Time to Reach the Maximum Observed Plasma Concentration (Tmax) of 1-OH-Midazolam (Midazolam Metabolite) Alone or in Combination With Erdafitinib
Hide Description Tmax is the time to reach the maximum observed plasma concentration of 1-OH-Midazolam alone or in combination with erdafitinib.
Time Frame Cycle 1 Day -2 (predose) up to Day 13 post dose (each cycle length=28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least 1 sample collected during treatment to determine the drug concentration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
Arm/Group Title DDI Study: 1-OH-Midazolam 2.5 mg Alone DDI Study: 1-OH-Midazolam 2.5 mg + Erdafitinib 8 mg
Hide Arm/Group Description:
Participants received single dose of pretreatment 1-OH-Midazolam 2.5 mg syrup, orally, once daily, starting from Day -2 through Day 13 of Cycle 1 (each cycle length=28 days).
Participants received single dose of pretreatment 1-OH-Midazolam 2.5 mg syrup, orally, once daily, starting from Day -2 through Day 13 of Cycle 1 along with erdafitinib 8 mg starting from Day 1 up to Day 15 of Cycle 1 (each cycle length=28 days).
Overall Number of Participants Analyzed 23 22
Median (Full Range)
Unit of Measure: Hours
0.58
(0.47 to 2.08)
0.58
(0.45 to 4.00)
7.Primary Outcome
Title Drug-Drug Interaction (DDI) Substudy: Time to Reach the Maximum Observed Plasma Concentration (Tmax) of Metformin Alone or in Combination With Erdafitinib
Hide Description Tmax is the time to reach maximum observed plasma concentration of metformin alone or in combination with erdafitinib
Time Frame Cycle 1 Day -1 (predose) up to Day 14 post dose (each cycle length=28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least 1 sample collected during treatment to determine the drug concentration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
Arm/Group Title DDI Study: Metformin 1000 mg Alone DDI Study: Metformin 1000 mg + Erdafitinib 8 mg
Hide Arm/Group Description:
Participants received single dose of metformin 1000 mg tablet, orally, once daily, starting from Day -1 through Day 14 of Cycle 1 (each cycle length=28 days).
Participants received single dose of metformin 1000 mg tablet, orally, once daily, starting from Day -1 through Day 14 of Cycle 1 along with erdafitinib 8 mg starting from Day 1 up to Day 15 of Cycle 1 (each cycle length=28 days).
Overall Number of Participants Analyzed 20 19
Median (Full Range)
Unit of Measure: Hours
2.04
(0.42 to 5.00)
3.00
(0.50 to 8.08)
8.Primary Outcome
Title Drug-Drug Interaction (DDI) Substudy: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUC[0-last]) of Midazolam Alone or in Combination With Erdafitinib
Hide Description AUC(0-last) is the area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration of midazolam alone or in combination with erdafitinib.
Time Frame Cycle 1 Day -2 (predose) up to Day 13 post dose (each cycle length=28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least 1 sample collected during treatment to determine the drug concentration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
Arm/Group Title DDI Study: Midazolam 2.5 mg Alone DDI Study: Midazolam 2.5 mg + Erdafitinib 8 mg
Hide Arm/Group Description:
Participants received single dose of pretreatment midazolam 2.5 mg syrup, orally, once daily, starting from Day -2 through Day 13 of Cycle 1 (each cycle length=28 days).
Participants received single dose of pretreatment midazolam 2.5 mg syrup, orally, once daily, starting from Day -2 through Day 13 of Cycle 1 along with erdafitinib 8 mg starting from Day 1 up to Day 15 of Cycle 1 (each cycle length=28 days).
Overall Number of Participants Analyzed 23 22
Mean (Standard Deviation)
Unit of Measure: Nanograms hours per milliliter (ng*h/mL)
64.4  (26.8) 57.1  (27.2)
9.Primary Outcome
Title Drug-Drug Interaction (DDI) Substudy: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUC[0-last]) of 1-OH-Midazolam (Midazolam Metabolite) Alone or in Combination With Erdafitinib
Hide Description AUC(0-last) is the area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration of 1-OH-Midazolam alone or in combination with erdafitinib.
Time Frame Cycle 1 Day -2 (predose) up to Day 13 post dose (each cycle length=28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least 1 sample collected during treatment to determine the drug concentration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
Arm/Group Title DDI Study: 1-OH-Midazolam 2.5 mg Alone DDI Study: 1-OH-Midazolam 2.5 mg + Erdafitinib 8 mg
Hide Arm/Group Description:
Participants received single dose of pretreatment 1-OH-Midazolam 2.5 mg syrup, orally, once daily, starting from Day -2 through Day 13 of Cycle 1 (each cycle length=28 days).
Participants received single dose of pretreatment 1-OH-Midazolam 2.5 mg syrup, orally, once daily, starting from Day -2 through Day 13 of Cycle 1 along with erdafitinib 8 mg starting from Day 1 up to Day 15 of Cycle 1 (each cycle length=28 days).
Overall Number of Participants Analyzed 23 22
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
15.8  (9.59) 15.1  (10.4)
10.Primary Outcome
Title Drug-Drug Interaction (DDI) Substudy: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUC[0-last]) of Metformin Alone or in Combination With Erdafitinib
Hide Description AUC(0-last) is the area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration of metformin alone or in combination with erdafitinib.
Time Frame Cycle 1 Day -1 (predose) up to Day 14 post dose (each cycle length=28 days)
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Hide Analysis Population Description
Pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least 1 sample collected during treatment to determine the drug concentration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
Arm/Group Title DDI Study: Metformin 1000 mg Alone DDI Study: Metformin 1000 mg + Erdafitinib 8 mg
Hide Arm/Group Description:
Participants received single dose of metformin 1000 mg tablet, orally, once daily, starting from Day -1 through Day 14 of Cycle 1 (each cycle length=28 days).
Participants received single dose of metformin 1000 mg tablet, orally, once daily, starting from Day -1 through Day 14 of Cycle 1 along with erdafitinib 8 mg starting from Day 1 up to Day 15 of Cycle 1 (each cycle length=28 days).
Overall Number of Participants Analyzed 20 19
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
22015  (11967) 26917  (17973)
11.Primary Outcome
Title Drug-Drug Interaction (DDI) Substudy: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Infinite Time (AUC[0-Infinity]) of Midazolam Alone or in Combination With Erdafitinib
Hide Description AUC(0-Infinity) is the area under the plasma concentration versus time curve from time 0 to the infinite time of midazolam alone or in combination with erdafitinib.
Time Frame Cycle 1 Day -2 (predose) up to Day 13 post dose (each cycle length=28 days)
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Hide Analysis Population Description
Pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least 1 sample collected during treatment to determine the drug concentration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
Arm/Group Title DDI Study: Midazolam 2.5 mg Alone DDI Study: Midazolam 2.5 mg + Erdafitinib 8 mg
Hide Arm/Group Description:
Participants received single dose of pretreatment midazolam 2.5 mg syrup, orally, once daily, starting from Day -2 through Day 13 of Cycle 1 (each cycle length=28 days).
Participants received single dose of pretreatment midazolam 2.5 mg syrup, orally, once daily, starting from Day -2 through Day 13 of Cycle 1 along with erdafitinib 8 mg starting from Day 1 up to Day 15 of Cycle 1 (each cycle length=28 days).
Overall Number of Participants Analyzed 20 17
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
69.8  (30.5) 55.9  (28.2)
12.Primary Outcome
Title Drug-Drug Interaction (DDI) Substudy: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Infinite Time (AUC[0-Infinity]) of 1-OH-Midazolam (Midazolam Metabolite) Alone or in Combination With Erdafitinib
Hide Description AUC(0-Infinity) is the area under the plasma concentration versus time curve from time 0 to the infinite time of 1-OH-Midazolam alone or in combination with erdafitinib.
Time Frame Cycle 1 Day -2 (predose) up to Day 13 post dose (each cycle length=28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least 1 sample collected during treatment to determine the drug concentration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
Arm/Group Title DDI Study: 1-OH-Midazolam 2.5 mg Alone DDI Study: 1-OH-Midazolam 2.5 mg + Erdafitinib 8 mg
Hide Arm/Group Description:
Participants received single dose of pretreatment 1-OH-Midazolam 2.5 mg syrup, orally, once daily, starting from Day -2 through Day 13 of Cycle 1 (each cycle length=28 days).
Participants received single dose of pretreatment 1-OH-Midazolam 2.5 mg syrup, orally, once daily, starting from Day -2 through Day 13 of Cycle 1 along with erdafitinib 8 mg starting from Day 1 up to Day 15 of Cycle 1 (each cycle length=28 days).
Overall Number of Participants Analyzed 18 13
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
18.1  (10.8) 18.4  (13.2)
13.Primary Outcome
Title Drug-Drug Interaction (DDI) Substudy: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Infinite Time (AUC[0-Infinity]) of Metformin Alone or in Combination With Erdafitinib
Hide Description AUC(0-Infinity) is the area under the plasma concentration versus time curve from time 0 to the infinite time of metformin alone or in combination with erdafitinib
Time Frame Cycle 1 Day -1 (predose) up to Day 14 post dose (each cycle length=28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least 1 sample collected during treatment to determine the drug concentration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
Arm/Group Title DDI Study: Metformin 1000 mg Alone DDI Study: Metformin 1000 mg + Erdafitinib 8 mg
Hide Arm/Group Description:
Participants received single dose of metformin 1000 mg tablet, orally, once daily, starting from Day -1 through Day 14 of Cycle 1 (each cycle length=28 days).
Participants received single dose of metformin 1000 mg tablet, orally, once daily, starting from Day -1 through Day 14 of Cycle 1 along with erdafitinib 8 mg starting from Day 1 up to Day 15 of Cycle 1 (each cycle length=28 days).
Overall Number of Participants Analyzed 20 17
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
22917  (12539) 28853  (21738)
14.Secondary Outcome
Title Main Study: Progression-free Survival (PFS)
Hide Description Progression-free survival is defined as the duration from the date of the first dose of study drug until the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study) or death due to any cause, whichever occurs first, regardless of the use of subsequent anticancer therapy. As per RECIST version 1.1, CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must had reduction in the short axis to less than (<) 10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time Frame From screening up to 6 years 2 months
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Hide Analysis Population Description
The population included participants who received at least 1 dose of study drug.
Arm/Group Title Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg
Hide Arm/Group Description:
Participants received single dose of erdafitinib 10 mg tablet, orally, once daily, starting from Day 1 through Day 7 and from Day 15 through Day 21 and so on, that is 7-day on and off in each subsequent 28-day cycles starting from Cycle 1. Based on serum phosphate (PO4) levels, there was an option to up-titrate erdafitinib dose to 12 mg, orally, once daily starting from Cycle 2 Day 1 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.
Participants received single dose of erdafitinib 6 mg tablet, orally, once daily, starting from Day 1 through Day 28 in each subsequent 28-day cycles starting from Cycle 1. Based on serum PO4 levels, there was an option to up-titrate erdafitinib dose to 8 mg, orally, once daily starting from Cycle 2 Day 1 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.
Participants received single dose of erdafitinib 8 mg tablet, orally, once daily, starting from Day 1 through Day 28 in each subsequent 28-day cycles starting from Cycle 1. Based on serum PO4 levels, there was an option to up-titrate erdafitinib dose to 9 mg, orally, once daily starting from Cycle 1 Day 15 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.
Overall Number of Participants Analyzed 33 78 101
Median (Full Range)
Unit of Measure: months
4.80
(1.1 to 25.3)
5.26
(0.4 to 57.9)
5.52
(0.0 to 51.5)
15.Secondary Outcome
Title Main Study: Duration of Response (DoR)
Hide Description DOR is defined as the time (in months) from the date of first observation of response (PR or CR) to the date of the first observation of progression or date of death, whatever the cause based on the RECIST version 1.1. CR: disappearance of all target and non-target lesions. All pathological (whether target or non-target) must have a reduction in their short axis <10 mm. PR: at least a 30% decrease in the SOD of target lesions, taking as reference the baseline sum diameters. PD was defined as at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.
Time Frame From screening up to 6 years 2 months
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Hide Analysis Population Description
The population included participants who received at least 1 dose of study drug and who had CR or PR.
Arm/Group Title Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg
Hide Arm/Group Description:
Participants received single dose of erdafitinib 10 mg tablet, orally, once daily, starting from Day 1 through Day 7 and from Day 15 through Day 21 and so on, that is 7-day on and off in each subsequent 28-day cycles starting from Cycle 1. Based on serum phosphate (PO4) levels, there was an option to up-titrate erdafitinib dose to 12 mg, orally, once daily starting from Cycle 2 Day 1 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.
Participants received single dose of erdafitinib 6 mg tablet, orally, once daily, starting from Day 1 through Day 28 in each subsequent 28-day cycles starting from Cycle 1. Based on serum PO4 levels, there was an option to up-titrate erdafitinib dose to 8 mg, orally, once daily starting from Cycle 2 Day 1 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.
Participants received single dose of erdafitinib 8 mg tablet, orally, once daily, starting from Day 1 through Day 28 in each subsequent 28-day cycles starting from Cycle 1. Based on serum PO4 levels, there was an option to up-titrate erdafitinib dose to 9 mg, orally, once daily starting from Cycle 1 Day 15 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.
Overall Number of Participants Analyzed 7 27 40
Median (Full Range)
Unit of Measure: months
13.37
(4.2 to 19.4)
4.90
(2.5 to 56.5)
5.98
(2.4 to 50.2)
16.Secondary Outcome
Title Main Study: Overall Survival
Hide Description Overall survival is defined as the time from the date of first dose of study drug to the date of the participant's death from any cause.
Time Frame From screening up to 6 years 2 months
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The population included participants who received at least 1 dose of study drug.
Arm/Group Title Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg
Hide Arm/Group Description:
Participants received single dose of erdafitinib 10 mg tablet, orally, once daily, starting from Day 1 through Day 7 and from Day 15 through Day 21 and so on, that is 7-day on and off in each subsequent 28-day cycles starting from Cycle 1. Based on serum phosphate (PO4) levels, there was an option to up-titrate erdafitinib dose to 12 mg, orally, once daily starting from Cycle 2 Day 1 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.
Participants received single dose of erdafitinib 6 mg tablet, orally, once daily, starting from Day 1 through Day 28 in each subsequent 28-day cycles starting from Cycle 1. Based on serum PO4 levels, there was an option to up-titrate erdafitinib dose to 8 mg, orally, once daily starting from Cycle 2 Day 1 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.
Participants received single dose of erdafitinib 8 mg tablet, orally, once daily, starting from Day 1 through Day 28 in each subsequent 28-day cycles starting from Cycle 1. Based on serum PO4 levels, there was an option to up-titrate erdafitinib dose to 9 mg, orally, once daily starting from Cycle 1 Day 15 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.
Overall Number of Participants Analyzed 33 78 101
Median (Full Range)
Unit of Measure: months
7.46
(1.7 to 64.0)
8.64
(0.4 to 60.1)
11.30
(0.7 to 56.9)
17.Secondary Outcome
Title Main Study: Percentage of Participants With Treatment-emergent Adverse Event (TEAEs)
Hide Description Percentage of participants with TEAEs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are those events that occurred from first dose date through 30 days after last dose date, or day before subsequent anticancer therapy, whichever occurs first.
Time Frame From Day 1 up to 6 years 2 months
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Hide Analysis Population Description
The population included participants who received at least 1 dose of study drug.
Arm/Group Title Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg
Hide Arm/Group Description:
Participants received single dose of erdafitinib 10 mg tablet, orally, once daily, starting from Day 1 through Day 7 and from Day 15 through Day 21 and so on, that is 7-day on and off in each subsequent 28-day cycles starting from Cycle 1. Based on serum phosphate (PO4) levels, there was an option to up-titrate erdafitinib dose to 12 mg, orally, once daily starting from Cycle 2 Day 1 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.
Participants received single dose of erdafitinib 6 mg tablet, orally, once daily, starting from Day 1 through Day 28 in each subsequent 28-day cycles starting from Cycle 1. Based on serum PO4 levels, there was an option to up-titrate erdafitinib dose to 8 mg, orally, once daily starting from Cycle 2 Day 1 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.
Participants received single dose of erdafitinib 8 mg tablet, orally, once daily, starting from Day 1 through Day 28 in each subsequent 28-day cycles starting from Cycle 1. Based on serum PO4 levels, there was an option to up-titrate erdafitinib dose to 9 mg, orally, once daily starting from Cycle 1 Day 15 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.
Overall Number of Participants Analyzed 33 78 101
Measure Type: Number
Unit of Measure: Percentage of Participants
100 100 100
18.Secondary Outcome
Title Main Study: Plasma Concentration of Erdafitinib at 2 Hours (C2h)
Hide Description C2h is the plasma concentration of erdafitinib at 2 hours.
Time Frame Cycle 1 Days 1 and 21: Pre-dose up to 2 hours post-dose (each cycle length=28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least 1 sample collected during treatment to determine the drug concentration. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies participants evaluable for this outcome measure at specified timepoints.
Arm/Group Title Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg
Hide Arm/Group Description:
Participants received single dose of erdafitinib 10 mg tablet, orally, once daily, starting from Day 1 through Day 7 and from Day 15 through Day 21 and so on, that is 7-day on and off in each subsequent 28-day cycles starting from Cycle 1. Based on serum phosphate (PO4) levels, there was an option to up-titrate erdafitinib dose to 12 mg, orally, once daily starting from Cycle 2 Day 1 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.
Participants received single dose of erdafitinib 6 mg tablet, orally, once daily, starting from Day 1 through Day 28 in each subsequent 28-day cycles starting from Cycle 1. Based on serum PO4 levels, there was an option to up-titrate erdafitinib dose to 8 mg, orally, once daily starting from Cycle 2 Day 1 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.
Participants received single dose of erdafitinib 8 mg tablet, orally, once daily, starting from Day 1 through Day 28 in each subsequent 28-day cycles starting from Cycle 1. Based on serum PO4 levels, there was an option to up-titrate erdafitinib dose to 9 mg, orally, once daily starting from Cycle 1 Day 15 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.
Overall Number of Participants Analyzed 32 74 92
Mean (Standard Deviation)
Unit of Measure: ng/mL
Cycle 1 Day 1 Number Analyzed 32 participants 74 participants 92 participants
529.5  (224.9) 311.0  (134.8) 373.0  (168.1)
Cycle 1 Day 21 Number Analyzed 23 participants 59 participants 45 participants
1686.5  (872.3) 1255.1  (640.0) 1371.4  (586.6)
19.Secondary Outcome
Title Main Study: Plasma Concentration of Erdafitinib at 4 Hours (C4h)
Hide Description C4h is the plasma concentration of erdafitinib at 4 hours.
Time Frame Cycle 1 Days 1 and 21: Pre-dose up to 4 hours post-dose (each cycle length=28 days)
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Hide Analysis Population Description
Pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least 1 sample collected during treatment to determine the drug concentration. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies participants evaluable for this outcome measure at specified timepoints.
Arm/Group Title Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg
Hide Arm/Group Description:
Participants received single dose of erdafitinib 10 mg tablet, orally, once daily, starting from Day 1 through Day 7 and from Day 15 through Day 21 and so on, that is 7-day on and off in each subsequent 28-day cycles starting from Cycle 1. Based on serum phosphate (PO4) levels, there was an option to up-titrate erdafitinib dose to 12 mg, orally, once daily starting from Cycle 2 Day 1 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.
Participants received single dose of erdafitinib 6 mg tablet, orally, once daily, starting from Day 1 through Day 28 in each subsequent 28-day cycles starting from Cycle 1. Based on serum PO4 levels, there was an option to up-titrate erdafitinib dose to 8 mg, orally, once daily starting from Cycle 2 Day 1 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.
Participants received single dose of erdafitinib 8 mg tablet, orally, once daily, starting from Day 1 through Day 28 in each subsequent 28-day cycles starting from Cycle 1. Based on serum PO4 levels, there was an option to up-titrate erdafitinib dose to 9 mg, orally, once daily starting from Cycle 1 Day 15 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.
Overall Number of Participants Analyzed 32 74 91
Mean (Standard Deviation)
Unit of Measure: ng/mL
Cycle 1 Day 1 Number Analyzed 32 participants 74 participants 91 participants
504.0  (189.6) 290.0  (117.9) 365.3  (155.6)
Cycle 1 Day 21 Number Analyzed 24 participants 60 participants 46 participants
1753.4  (917.8) 1257.4  (663.2) 1329.9  (550.1)
Time Frame Main study: From Day 1 up to 6 years 2 months; DDI study: From Day 1 up to 1 year 6 months
Adverse Event Reporting Description The population included participants who received at least 1 dose of study drug.
 
Arm/Group Title Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg Drug-Drug Interaction (DDI) Sub-study: Midazolam 2.5 mg + Metformin 1000 mg + Erdafitinib 8/9 mg
Hide Arm/Group Description Participants received single dose of erdafitinib 10 mg tablet, orally, once daily, starting from Day 1 through Day 7 and from Day 15 through Day 21 and so on, that is 7-day on and off in each subsequent 28-day cycles starting from Cycle 1. Based on serum phosphate (PO4) levels, there was an option to up-titrate erdafitinib dose to 12 mg, orally, once daily starting from Cycle 2 Day 1 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation. Participants received single dose of erdafitinib 6 mg tablet, orally, once daily, starting from Day 1 through Day 28 in each subsequent 28-day cycles starting from Cycle 1. Based on serum PO4 levels, there was an option to up-titrate erdafitinib dose to 8 mg, orally, once daily starting from Cycle 2 Day 1 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation. Participants received single dose of erdafitinib 8 mg tablet, orally, once daily, starting from Day 1 through Day 28 in each subsequent 28-day cycles starting from Cycle 1. Based on serum PO4 levels, there was an option to up-titrate erdafitinib dose to 9 mg, orally, once daily starting from Cycle 1 Day 15 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation. Participants received pretreatment with single doses of midazolam 2.5 mg syrup orally on Day -2 and metformin 1000 mg tablet orally on Day -1 along with erdafitinib 8 mg tablet, orally, on 28-day cycles starting from Cycle 1 Day 1 to Day 15 (or up-titrated to 9 mg on Day 15 based on Day 14 serum PO4 levels) until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.
All-Cause Mortality
Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg Drug-Drug Interaction (DDI) Sub-study: Midazolam 2.5 mg + Metformin 1000 mg + Erdafitinib 8/9 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   31/33 (93.94%)   62/78 (79.49%)   83/101 (82.18%)   3/25 (12.00%) 
Hide Serious Adverse Events
Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg Drug-Drug Interaction (DDI) Sub-study: Midazolam 2.5 mg + Metformin 1000 mg + Erdafitinib 8/9 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   14/33 (42.42%)   39/78 (50.00%)   47/101 (46.53%)   9/25 (36.00%) 
Blood and lymphatic system disorders         
Anaemia * 1  1/33 (3.03%)  0/78 (0.00%)  1/101 (0.99%)  0/25 (0.00%) 
Cardiac disorders         
Acute Coronary Syndrome * 1  0/33 (0.00%)  1/78 (1.28%)  0/101 (0.00%)  0/25 (0.00%) 
Acute Myocardial Infarction * 1  0/33 (0.00%)  0/78 (0.00%)  1/101 (0.99%)  0/25 (0.00%) 
Myocardial Infarction * 1  0/33 (0.00%)  0/78 (0.00%)  1/101 (0.99%)  0/25 (0.00%) 
Eye disorders         
Angle Closure Glaucoma * 1  0/33 (0.00%)  0/78 (0.00%)  1/101 (0.99%)  0/25 (0.00%) 
Cataract * 1  1/33 (3.03%)  1/78 (1.28%)  2/101 (1.98%)  0/25 (0.00%) 
Corneal Erosion * 1  0/33 (0.00%)  0/78 (0.00%)  1/101 (0.99%)  0/25 (0.00%) 
Detachment of Retinal Pigment Epithelium * 1  0/33 (0.00%)  0/78 (0.00%)  1/101 (0.99%)  0/25 (0.00%) 
Dry Eye * 1  0/33 (0.00%)  1/78 (1.28%)  0/101 (0.00%)  0/25 (0.00%) 
Keratitis * 1  0/33 (0.00%)  1/78 (1.28%)  2/101 (1.98%)  0/25 (0.00%) 
Maculopathy * 1  0/33 (0.00%)  0/78 (0.00%)  1/101 (0.99%)  0/25 (0.00%) 
Optic Atrophy * 1  0/33 (0.00%)  0/78 (0.00%)  1/101 (0.99%)  0/25 (0.00%) 
Retinal Detachment * 1  0/33 (0.00%)  0/78 (0.00%)  1/101 (0.99%)  0/25 (0.00%) 
Retinal Oedema * 1  0/33 (0.00%)  0/78 (0.00%)  1/101 (0.99%)  0/25 (0.00%) 
Retinopathy * 1  0/33 (0.00%)  0/78 (0.00%)  1/101 (0.99%)  0/25 (0.00%) 
Vision Blurred * 1  0/33 (0.00%)  1/78 (1.28%)  0/101 (0.00%)  0/25 (0.00%) 
Visual Acuity Reduced * 1  0/33 (0.00%)  0/78 (0.00%)  1/101 (0.99%)  0/25 (0.00%) 
Vitreous Detachment * 1  0/33 (0.00%)  0/78 (0.00%)  1/101 (0.99%)  0/25 (0.00%) 
Gastrointestinal disorders         
Abdominal Pain * 1  0/33 (0.00%)  1/78 (1.28%)  1/101 (0.99%)  0/25 (0.00%) 
Abdominal Pain Lower * 1  0/33 (0.00%)  0/78 (0.00%)  1/101 (0.99%)  0/25 (0.00%) 
Colitis * 1  0/33 (0.00%)  0/78 (0.00%)  2/101 (1.98%)  0/25 (0.00%) 
Constipation * 1  0/33 (0.00%)  1/78 (1.28%)  0/101 (0.00%)  0/25 (0.00%) 
Diarrhoea * 1  0/33 (0.00%)  1/78 (1.28%)  0/101 (0.00%)  0/25 (0.00%) 
Enterocutaneous Fistula * 1  0/33 (0.00%)  1/78 (1.28%)  0/101 (0.00%)  0/25 (0.00%) 
Gastrointestinal Haemorrhage * 1  0/33 (0.00%)  1/78 (1.28%)  0/101 (0.00%)  0/25 (0.00%) 
Ileus * 1  0/33 (0.00%)  0/78 (0.00%)  1/101 (0.99%)  0/25 (0.00%) 
Ileus Paralytic * 1  0/33 (0.00%)  0/78 (0.00%)  0/101 (0.00%)  1/25 (4.00%) 
Inguinal Hernia * 1  0/33 (0.00%)  0/78 (0.00%)  1/101 (0.99%)  0/25 (0.00%) 
Intestinal Obstruction * 1  1/33 (3.03%)  0/78 (0.00%)  2/101 (1.98%)  2/25 (8.00%) 
Large Intestinal Obstruction * 1  0/33 (0.00%)  1/78 (1.28%)  0/101 (0.00%)  0/25 (0.00%) 
Nausea * 1  0/33 (0.00%)  0/78 (0.00%)  2/101 (1.98%)  0/25 (0.00%) 
Pancreatitis Acute * 1  0/33 (0.00%)  0/78 (0.00%)  1/101 (0.99%)  0/25 (0.00%) 
Rectal Haemorrhage * 1  0/33 (0.00%)  0/78 (0.00%)  0/101 (0.00%)  1/25 (4.00%) 
Small Intestinal Obstruction * 1  0/33 (0.00%)  1/78 (1.28%)  1/101 (0.99%)  0/25 (0.00%) 
Stomatitis * 1  0/33 (0.00%)  1/78 (1.28%)  0/101 (0.00%)  0/25 (0.00%) 
Subileus * 1  0/33 (0.00%)  1/78 (1.28%)  1/101 (0.99%)  0/25 (0.00%) 
Vomiting * 1  1/33 (3.03%)  0/78 (0.00%)  0/101 (0.00%)  0/25 (0.00%) 
General disorders         
Asthenia * 1  0/33 (0.00%)  2/78 (2.56%)  2/101 (1.98%)  0/25 (0.00%) 
Breakthrough Pain * 1  0/33 (0.00%)  0/78 (0.00%)  1/101 (0.99%)  0/25 (0.00%) 
Condition Aggravated * 1  0/33 (0.00%)  0/78 (0.00%)  1/101 (0.99%)  0/25 (0.00%) 
Disease Progression * 1  0/33 (0.00%)  1/78 (1.28%)  0/101 (0.00%)  0/25 (0.00%) 
General Physical Health Deterioration * 1  1/33 (3.03%)  2/78 (2.56%)  2/101 (1.98%)  0/25 (0.00%) 
Multiple Organ Dysfunction Syndrome * 1  0/33 (0.00%)  1/78 (1.28%)  0/101 (0.00%)  0/25 (0.00%) 
Oedema Peripheral * 1  0/33 (0.00%)  0/78 (0.00%)  1/101 (0.99%)  0/25 (0.00%) 
Performance Status Decreased * 1  0/33 (0.00%)  0/78 (0.00%)  1/101 (0.99%)  0/25 (0.00%) 
Pyrexia * 1  0/33 (0.00%)  1/78 (1.28%)  0/101 (0.00%)  1/25 (4.00%) 
Immune system disorders         
Anaphylactic Reaction * 1  0/33 (0.00%)  0/78 (0.00%)  1/101 (0.99%)  0/25 (0.00%) 
Infections and infestations         
Atypical Pneumonia * 1  0/33 (0.00%)  1/78 (1.28%)  0/101 (0.00%)  0/25 (0.00%) 
Bacterial Sepsis * 1  0/33 (0.00%)  0/78 (0.00%)  1/101 (0.99%)  0/25 (0.00%) 
Cellulitis * 1  1/33 (3.03%)  0/78 (0.00%)  0/101 (0.00%)  0/25 (0.00%) 
Clostridium Difficile Colitis * 1  1/33 (3.03%)  0/78 (0.00%)  0/101 (0.00%)  0/25 (0.00%) 
Eye Abscess * 1  0/33 (0.00%)  0/78 (0.00%)  1/101 (0.99%)  0/25 (0.00%) 
Herpes Zoster * 1  0/33 (0.00%)  0/78 (0.00%)  1/101 (0.99%)  0/25 (0.00%) 
Infective Corneal Ulcer * 1  0/33 (0.00%)  0/78 (0.00%)  1/101 (0.99%)  0/25 (0.00%) 
Kidney Infection * 1  0/33 (0.00%)  0/78 (0.00%)  1/101 (0.99%)  0/25 (0.00%) 
Lower Respiratory Tract Infection * 1  0/33 (0.00%)  1/78 (1.28%)  0/101 (0.00%)  0/25 (0.00%) 
Pelvic Abscess * 1  0/33 (0.00%)  1/78 (1.28%)  0/101 (0.00%)  0/25 (0.00%) 
Periorbital Abscess * 1  0/33 (0.00%)  1/78 (1.28%)  0/101 (0.00%)  0/25 (0.00%) 
Pneumonia * 1  1/33 (3.03%)  1/78 (1.28%)  2/101 (1.98%)  0/25 (0.00%) 
Sepsis * 1  1/33 (3.03%)  2/78 (2.56%)  1/101 (0.99%)  0/25 (0.00%) 
Septic Shock * 1  0/33 (0.00%)  1/78 (1.28%)  1/101 (0.99%)  0/25 (0.00%) 
Sialoadenitis * 1  0/33 (0.00%)  1/78 (1.28%)  0/101 (0.00%)  0/25 (0.00%) 
Urinary Tract Infection * 1  0/33 (0.00%)  4/78 (5.13%)  4/101 (3.96%)  1/25 (4.00%) 
Urosepsis * 1  0/33 (0.00%)  3/78 (3.85%)  2/101 (1.98%)  0/25 (0.00%) 
Injury, poisoning and procedural complications         
Bone Contusion * 1  0/33 (0.00%)  0/78 (0.00%)  0/101 (0.00%)  1/25 (4.00%) 
Exposure to Toxic Agent * 1  0/33 (0.00%)  1/78 (1.28%)  0/101 (0.00%)  0/25 (0.00%) 
Femoral Neck Fracture * 1  0/33 (0.00%)  1/78 (1.28%)  0/101 (0.00%)  0/25 (0.00%) 
Lumbar Vertebral Fracture * 1  0/33 (0.00%)  1/78 (1.28%)  0/101 (0.00%)  0/25 (0.00%) 
Overdose * 1  0/33 (0.00%)  0/78 (0.00%)  0/101 (0.00%)  1/25 (4.00%) 
Investigations         
Eastern Cooperative Oncology Group Performance Status Worsened * 1  0/33 (0.00%)  0/78 (0.00%)  1/101 (0.99%)  0/25 (0.00%) 
Metabolism and nutrition disorders         
Cachexia * 1  0/33 (0.00%)  1/78 (1.28%)  0/101 (0.00%)  0/25 (0.00%) 
Decreased Appetite * 1  0/33 (0.00%)  1/78 (1.28%)  0/101 (0.00%)  0/25 (0.00%) 
Dehydration * 1  0/33 (0.00%)  1/78 (1.28%)  0/101 (0.00%)  0/25 (0.00%) 
Hypercalcaemia * 1  0/33 (0.00%)  1/78 (1.28%)  1/101 (0.99%)  1/25 (4.00%) 
Hypoglycaemia * 1  1/33 (3.03%)  0/78 (0.00%)  0/101 (0.00%)  0/25 (0.00%) 
Hyponatraemia * 1  0/33 (0.00%)  0/78 (0.00%)  1/101 (0.99%)  0/25 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia * 1  0/33 (0.00%)  1/78 (1.28%)  0/101 (0.00%)  0/25 (0.00%) 
Back Pain * 1  1/33 (3.03%)  1/78 (1.28%)  0/101 (0.00%)  0/25 (0.00%) 
Pain in Extremity * 1  0/33 (0.00%)  2/78 (2.56%)  0/101 (0.00%)  0/25 (0.00%) 
Spinal Pain * 1  1/33 (3.03%)  0/78 (0.00%)  0/101 (0.00%)  0/25 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Cancer Pain * 1  0/33 (0.00%)  1/78 (1.28%)  0/101 (0.00%)  0/25 (0.00%) 
Ureteral Neoplasm * 1  0/33 (0.00%)  0/78 (0.00%)  1/101 (0.99%)  0/25 (0.00%) 
Nervous system disorders         
Brain Oedema * 1  0/33 (0.00%)  1/78 (1.28%)  0/101 (0.00%)  0/25 (0.00%) 
Headache * 1  0/33 (0.00%)  0/78 (0.00%)  1/101 (0.99%)  0/25 (0.00%) 
Hypoaesthesia * 1  0/33 (0.00%)  1/78 (1.28%)  0/101 (0.00%)  0/25 (0.00%) 
Loss of Consciousness * 1  0/33 (0.00%)  1/78 (1.28%)  0/101 (0.00%)  0/25 (0.00%) 
Mental Impairment * 1  0/33 (0.00%)  0/78 (0.00%)  1/101 (0.99%)  0/25 (0.00%) 
Seizure * 1  0/33 (0.00%)  0/78 (0.00%)  0/101 (0.00%)  1/25 (4.00%) 
Somnolence * 1  0/33 (0.00%)  1/78 (1.28%)  0/101 (0.00%)  0/25 (0.00%) 
Syncope * 1  0/33 (0.00%)  1/78 (1.28%)  0/101 (0.00%)  0/25 (0.00%) 
Product Issues         
Device Dislocation * 1  1/33 (3.03%)  0/78 (0.00%)  0/101 (0.00%)  0/25 (0.00%) 
Device Expulsion * 1  0/33 (0.00%)  1/78 (1.28%)  0/101 (0.00%)  0/25 (0.00%) 
Psychiatric disorders         
Confusional State * 1  1/33 (3.03%)  0/78 (0.00%)  0/101 (0.00%)  0/25 (0.00%) 
Hallucination, Visual * 1  0/33 (0.00%)  0/78 (0.00%)  1/101 (0.99%)  0/25 (0.00%) 
Renal and urinary disorders         
Acute Kidney Injury * 1  0/33 (0.00%)  1/78 (1.28%)  2/101 (1.98%)  1/25 (4.00%) 
Haematuria * 1  0/33 (0.00%)  1/78 (1.28%)  3/101 (2.97%)  1/25 (4.00%) 
Hydronephrosis * 1  0/33 (0.00%)  0/78 (0.00%)  2/101 (1.98%)  0/25 (0.00%) 
Nephrolithiasis * 1  0/33 (0.00%)  0/78 (0.00%)  1/101 (0.99%)  0/25 (0.00%) 
Nephropathy Toxic * 1  0/33 (0.00%)  0/78 (0.00%)  0/101 (0.00%)  1/25 (4.00%) 
Renal Failure * 1  0/33 (0.00%)  1/78 (1.28%)  1/101 (0.99%)  0/25 (0.00%) 
Renal Impairment * 1  1/33 (3.03%)  0/78 (0.00%)  1/101 (0.99%)  0/25 (0.00%) 
Renal Injury * 1  0/33 (0.00%)  1/78 (1.28%)  0/101 (0.00%)  0/25 (0.00%) 
Renal Pain * 1  0/33 (0.00%)  0/78 (0.00%)  1/101 (0.99%)  0/25 (0.00%) 
Urethral Stenosis * 1  0/33 (0.00%)  0/78 (0.00%)  1/101 (0.99%)  0/25 (0.00%) 
Urinary Retention * 1  0/33 (0.00%)  1/78 (1.28%)  1/101 (0.99%)  0/25 (0.00%) 
Urinary Tract Obstruction * 1  0/33 (0.00%)  0/78 (0.00%)  1/101 (0.99%)  0/25 (0.00%) 
Reproductive system and breast disorders         
Pelvic Pain * 1  0/33 (0.00%)  0/78 (0.00%)  1/101 (0.99%)  0/25 (0.00%) 
Vaginal Haemorrhage * 1  0/33 (0.00%)  1/78 (1.28%)  0/101 (0.00%)  0/25 (0.00%) 
Vulvovaginal Pain * 1  0/33 (0.00%)  0/78 (0.00%)  1/101 (0.99%)  0/25 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Dyspnoea * 1  2/33 (6.06%)  1/78 (1.28%)  2/101 (1.98%)  1/25 (4.00%) 
Haemoptysis * 1  0/33 (0.00%)  1/78 (1.28%)  0/101 (0.00%)  0/25 (0.00%) 
Hypoxia * 1  1/33 (3.03%)  0/78 (0.00%)  0/101 (0.00%)  0/25 (0.00%) 
Pleural Effusion * 1  0/33 (0.00%)  0/78 (0.00%)  0/101 (0.00%)  1/25 (4.00%) 
Pneumonitis * 1  1/33 (3.03%)  0/78 (0.00%)  0/101 (0.00%)  0/25 (0.00%) 
Pneumothorax * 1  0/33 (0.00%)  0/78 (0.00%)  1/101 (0.99%)  0/25 (0.00%) 
Respiratory Distress * 1  0/33 (0.00%)  1/78 (1.28%)  0/101 (0.00%)  0/25 (0.00%) 
Respiratory Failure * 1  0/33 (0.00%)  0/78 (0.00%)  0/101 (0.00%)  1/25 (4.00%) 
Skin and subcutaneous tissue disorders         
Erythema * 1  0/33 (0.00%)  0/78 (0.00%)  1/101 (0.99%)  0/25 (0.00%) 
Vascular disorders         
Deep Vein Thrombosis * 1  0/33 (0.00%)  1/78 (1.28%)  0/101 (0.00%)  0/25 (0.00%) 
Hypotension * 1  0/33 (0.00%)  1/78 (1.28%)  0/101 (0.00%)  0/25 (0.00%) 
Lymphoedema * 1  0/33 (0.00%)  1/78 (1.28%)  0/101 (0.00%)  0/25 (0.00%) 
1
Term from vocabulary, MedDRA Version 24.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg Drug-Drug Interaction (DDI) Sub-study: Midazolam 2.5 mg + Metformin 1000 mg + Erdafitinib 8/9 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   32/33 (96.97%)   78/78 (100.00%)   101/101 (100.00%)   25/25 (100.00%) 
Blood and lymphatic system disorders         
Anaemia * 1  8/33 (24.24%)  13/78 (16.67%)  23/101 (22.77%)  7/25 (28.00%) 
Thrombocytopenia * 1  2/33 (6.06%)  3/78 (3.85%)  6/101 (5.94%)  1/25 (4.00%) 
Eye disorders         
Blepharitis * 1  0/33 (0.00%)  1/78 (1.28%)  6/101 (5.94%)  0/25 (0.00%) 
Cataract * 1  1/33 (3.03%)  4/78 (5.13%)  4/101 (3.96%)  2/25 (8.00%) 
Chorioretinopathy * 1  2/33 (6.06%)  2/78 (2.56%)  7/101 (6.93%)  1/25 (4.00%) 
Dry Eye * 1  3/33 (9.09%)  7/78 (8.97%)  28/101 (27.72%)  2/25 (8.00%) 
Keratitis * 1  3/33 (9.09%)  1/78 (1.28%)  4/101 (3.96%)  2/25 (8.00%) 
Lacrimation Increased * 1  6/33 (18.18%)  13/78 (16.67%)  12/101 (11.88%)  4/25 (16.00%) 
Ocular Toxicity * 1  0/33 (0.00%)  0/78 (0.00%)  0/101 (0.00%)  2/25 (8.00%) 
Punctate Keratitis * 1  0/33 (0.00%)  0/78 (0.00%)  5/101 (4.95%)  3/25 (12.00%) 
Retinal Detachment * 1  1/33 (3.03%)  5/78 (6.41%)  3/101 (2.97%)  3/25 (12.00%) 
Vision Blurred * 1  5/33 (15.15%)  5/78 (6.41%)  18/101 (17.82%)  4/25 (16.00%) 
Visual Acuity Reduced * 1  0/33 (0.00%)  1/78 (1.28%)  7/101 (6.93%)  1/25 (4.00%) 
Visual Impairment * 1  1/33 (3.03%)  3/78 (3.85%)  7/101 (6.93%)  0/25 (0.00%) 
Gastrointestinal disorders         
Abdominal Pain * 1  5/33 (15.15%)  14/78 (17.95%)  8/101 (7.92%)  5/25 (20.00%) 
Abdominal Pain Upper * 1  1/33 (3.03%)  6/78 (7.69%)  9/101 (8.91%)  4/25 (16.00%) 
Constipation * 1  14/33 (42.42%)  20/78 (25.64%)  29/101 (28.71%)  8/25 (32.00%) 
Diarrhoea * 1  15/33 (45.45%)  39/78 (50.00%)  56/101 (55.45%)  15/25 (60.00%) 
Dry Mouth * 1  16/33 (48.48%)  31/78 (39.74%)  46/101 (45.54%)  9/25 (36.00%) 
Dyspepsia * 1  4/33 (12.12%)  9/78 (11.54%)  12/101 (11.88%)  1/25 (4.00%) 
Dysphagia * 1  0/33 (0.00%)  5/78 (6.41%)  6/101 (5.94%)  2/25 (8.00%) 
Gastrooesophageal Reflux Disease * 1  1/33 (3.03%)  1/78 (1.28%)  7/101 (6.93%)  0/25 (0.00%) 
Haemorrhoids * 1  2/33 (6.06%)  0/78 (0.00%)  2/101 (1.98%)  0/25 (0.00%) 
Nausea * 1  5/33 (15.15%)  16/78 (20.51%)  22/101 (21.78%)  4/25 (16.00%) 
Stomatitis * 1  16/33 (48.48%)  34/78 (43.59%)  60/101 (59.41%)  14/25 (56.00%) 
Vomiting * 1  8/33 (24.24%)  11/78 (14.10%)  15/101 (14.85%)  1/25 (4.00%) 
General disorders         
Asthenia * 1  10/33 (30.30%)  17/78 (21.79%)  22/101 (21.78%)  9/25 (36.00%) 
Chills * 1  2/33 (6.06%)  2/78 (2.56%)  2/101 (1.98%)  0/25 (0.00%) 
Fatigue * 1  7/33 (21.21%)  21/78 (26.92%)  33/101 (32.67%)  2/25 (8.00%) 
Mucosal Dryness * 1  1/33 (3.03%)  1/78 (1.28%)  2/101 (1.98%)  2/25 (8.00%) 
Oedema Peripheral * 1  5/33 (15.15%)  6/78 (7.69%)  10/101 (9.90%)  1/25 (4.00%) 
Pyrexia * 1  5/33 (15.15%)  14/78 (17.95%)  13/101 (12.87%)  2/25 (8.00%) 
Hepatobiliary disorders         
Hyperbilirubinaemia * 1  0/33 (0.00%)  2/78 (2.56%)  3/101 (2.97%)  2/25 (8.00%) 
Infections and infestations         
Conjunctivitis * 1  5/33 (15.15%)  7/78 (8.97%)  13/101 (12.87%)  3/25 (12.00%) 
Paronychia * 1  2/33 (6.06%)  12/78 (15.38%)  19/101 (18.81%)  5/25 (20.00%) 
Pneumonia * 1  1/33 (3.03%)  4/78 (5.13%)  2/101 (1.98%)  0/25 (0.00%) 
Sinusitis * 1  2/33 (6.06%)  2/78 (2.56%)  0/101 (0.00%)  0/25 (0.00%) 
Urinary Tract Infection * 1  4/33 (12.12%)  10/78 (12.82%)  15/101 (14.85%)  3/25 (12.00%) 
Investigations         
Alanine Aminotransferase Increased * 1  2/33 (6.06%)  9/78 (11.54%)  19/101 (18.81%)  9/25 (36.00%) 
Aspartate Aminotransferase Increased * 1  3/33 (9.09%)  9/78 (11.54%)  13/101 (12.87%)  9/25 (36.00%) 
Blood Alkaline Phosphatase Increased * 1  3/33 (9.09%)  7/78 (8.97%)  7/101 (6.93%)  2/25 (8.00%) 
Blood Creatinine Increased * 1  5/33 (15.15%)  7/78 (8.97%)  10/101 (9.90%)  2/25 (8.00%) 
Weight Decreased * 1  3/33 (9.09%)  8/78 (10.26%)  18/101 (17.82%)  2/25 (8.00%) 
Metabolism and nutrition disorders         
Decreased Appetite * 1  11/33 (33.33%)  28/78 (35.90%)  41/101 (40.59%)  6/25 (24.00%) 
Dehydration * 1  0/33 (0.00%)  3/78 (3.85%)  7/101 (6.93%)  0/25 (0.00%) 
Hypercalcaemia * 1  3/33 (9.09%)  4/78 (5.13%)  6/101 (5.94%)  0/25 (0.00%) 
Hyperglycaemia * 1  2/33 (6.06%)  2/78 (2.56%)  6/101 (5.94%)  0/25 (0.00%) 
Hyperkalaemia * 1  3/33 (9.09%)  2/78 (2.56%)  4/101 (3.96%)  0/25 (0.00%) 
Hyperphosphataemia * 1  16/33 (48.48%)  52/78 (66.67%)  79/101 (78.22%)  19/25 (76.00%) 
Hypocalcaemia * 1  2/33 (6.06%)  3/78 (3.85%)  4/101 (3.96%)  0/25 (0.00%) 
Hypomagnesaemia * 1  2/33 (6.06%)  6/78 (7.69%)  13/101 (12.87%)  1/25 (4.00%) 
Hyponatraemia * 1  2/33 (6.06%)  7/78 (8.97%)  12/101 (11.88%)  1/25 (4.00%) 
Hypophosphataemia * 1  3/33 (9.09%)  3/78 (3.85%)  8/101 (7.92%)  1/25 (4.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia * 1  9/33 (27.27%)  9/78 (11.54%)  8/101 (7.92%)  5/25 (20.00%) 
Back Pain * 1  4/33 (12.12%)  12/78 (15.38%)  5/101 (4.95%)  2/25 (8.00%) 
Muscle Spasms * 1  0/33 (0.00%)  2/78 (2.56%)  6/101 (5.94%)  0/25 (0.00%) 
Muscular Weakness * 1  2/33 (6.06%)  0/78 (0.00%)  2/101 (1.98%)  0/25 (0.00%) 
Musculoskeletal Chest Pain * 1  3/33 (9.09%)  1/78 (1.28%)  3/101 (2.97%)  0/25 (0.00%) 
Myalgia * 1  3/33 (9.09%)  2/78 (2.56%)  4/101 (3.96%)  2/25 (8.00%) 
Pain in Extremity * 1  5/33 (15.15%)  9/78 (11.54%)  14/101 (13.86%)  0/25 (0.00%) 
Nervous system disorders         
Dizziness * 1  2/33 (6.06%)  3/78 (3.85%)  5/101 (4.95%)  0/25 (0.00%) 
Dysgeusia * 1  7/33 (21.21%)  7/78 (8.97%)  33/101 (32.67%)  5/25 (20.00%) 
Headache * 1  1/33 (3.03%)  6/78 (7.69%)  7/101 (6.93%)  2/25 (8.00%) 
Paraesthesia * 1  0/33 (0.00%)  4/78 (5.13%)  3/101 (2.97%)  2/25 (8.00%) 
Partial Seizures * 1  0/33 (0.00%)  0/78 (0.00%)  0/101 (0.00%)  2/25 (8.00%) 
Peripheral Sensory Neuropathy * 1  1/33 (3.03%)  2/78 (2.56%)  5/101 (4.95%)  4/25 (16.00%) 
Taste Disorder * 1  3/33 (9.09%)  3/78 (3.85%)  10/101 (9.90%)  0/25 (0.00%) 
Tremor * 1  2/33 (6.06%)  1/78 (1.28%)  1/101 (0.99%)  0/25 (0.00%) 
Psychiatric disorders         
Anxiety * 1  3/33 (9.09%)  0/78 (0.00%)  5/101 (4.95%)  0/25 (0.00%) 
Insomnia * 1  3/33 (9.09%)  8/78 (10.26%)  9/101 (8.91%)  0/25 (0.00%) 
Renal and urinary disorders         
Dysuria * 1  0/33 (0.00%)  3/78 (3.85%)  6/101 (5.94%)  5/25 (20.00%) 
Haematuria * 1  3/33 (9.09%)  5/78 (6.41%)  11/101 (10.89%)  3/25 (12.00%) 
Pollakiuria * 1  0/33 (0.00%)  1/78 (1.28%)  2/101 (1.98%)  2/25 (8.00%) 
Renal Impairment * 1  1/33 (3.03%)  2/78 (2.56%)  8/101 (7.92%)  0/25 (0.00%) 
Reproductive system and breast disorders         
Pelvic Pain * 1  2/33 (6.06%)  1/78 (1.28%)  4/101 (3.96%)  0/25 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough * 1  2/33 (6.06%)  7/78 (8.97%)  11/101 (10.89%)  1/25 (4.00%) 
Dyspnoea * 1  6/33 (18.18%)  5/78 (6.41%)  7/101 (6.93%)  1/25 (4.00%) 
Epistaxis * 1  2/33 (6.06%)  6/78 (7.69%)  9/101 (8.91%)  1/25 (4.00%) 
Nasal Dryness * 1  3/33 (9.09%)  6/78 (7.69%)  9/101 (8.91%)  0/25 (0.00%) 
Oropharyngeal Pain * 1  0/33 (0.00%)  8/78 (10.26%)  10/101 (9.90%)  1/25 (4.00%) 
Pleural Effusion * 1  2/33 (6.06%)  2/78 (2.56%)  2/101 (1.98%)  0/25 (0.00%) 
Productive Cough * 1  0/33 (0.00%)  4/78 (5.13%)  1/101 (0.99%)  0/25 (0.00%) 
Pulmonary Embolism * 1  2/33 (6.06%)  1/78 (1.28%)  0/101 (0.00%)  0/25 (0.00%) 
Skin and subcutaneous tissue disorders         
Alopecia * 1  4/33 (12.12%)  10/78 (12.82%)  34/101 (33.66%)  3/25 (12.00%) 
Dry Skin * 1  9/33 (27.27%)  18/78 (23.08%)  34/101 (33.66%)  3/25 (12.00%) 
Erythema * 1  1/33 (3.03%)  1/78 (1.28%)  7/101 (6.93%)  1/25 (4.00%) 
Hyperkeratosis * 1  2/33 (6.06%)  2/78 (2.56%)  2/101 (1.98%)  0/25 (0.00%) 
Nail Discolouration * 1  1/33 (3.03%)  7/78 (8.97%)  13/101 (12.87%)  1/25 (4.00%) 
Nail Disorder * 1  0/33 (0.00%)  4/78 (5.13%)  11/101 (10.89%)  4/25 (16.00%) 
Nail Dystrophy * 1  2/33 (6.06%)  7/78 (8.97%)  17/101 (16.83%)  9/25 (36.00%) 
Onychalgia * 1  0/33 (0.00%)  0/78 (0.00%)  6/101 (5.94%)  0/25 (0.00%) 
Onycholysis * 1  7/33 (21.21%)  13/78 (16.67%)  19/101 (18.81%)  5/25 (20.00%) 
Onychomadesis * 1  1/33 (3.03%)  8/78 (10.26%)  7/101 (6.93%)  0/25 (0.00%) 
Palmar-Plantar Erythrodysaesthesia Syndrome * 1  2/33 (6.06%)  14/78 (17.95%)  25/101 (24.75%)  6/25 (24.00%) 
Pruritus * 1  1/33 (3.03%)  6/78 (7.69%)  6/101 (5.94%)  1/25 (4.00%) 
Rash * 1  1/33 (3.03%)  1/78 (1.28%)  7/101 (6.93%)  1/25 (4.00%) 
Skin Fissures * 1  2/33 (6.06%)  1/78 (1.28%)  6/101 (5.94%)  0/25 (0.00%) 
Vascular disorders         
Hypertension * 1  1/33 (3.03%)  0/78 (0.00%)  7/101 (6.93%)  0/25 (0.00%) 
Hypotension * 1  2/33 (6.06%)  6/78 (7.69%)  7/101 (6.93%)  2/25 (8.00%) 
1
Term from vocabulary, MedDRA Version 24.1
*
Indicates events were collected by non-systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Executive Medical Director
Organization: Janssen Research & Development, LLC
Phone: 844-434-4210
EMail: ClinicalTrialDisclosure@its.jnj.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02365597    
Other Study ID Numbers: CR105065
42756493BLC2001 ( Other Identifier: Janssen Research & Development, LLC )
2014-002408-26 ( EudraCT Number )
2023-510273-34-00 ( Registry Identifier: EUCT number )
First Submitted: January 29, 2015
First Posted: February 19, 2015
Results First Submitted: September 14, 2023
Results First Posted: October 10, 2023
Last Update Posted: May 7, 2024