Trial Outcomes & Findings for A Study of ASP2215 in Combination With Erlotinib in Subjects With Epidermal Growth Factor Receptor (EGFR) Activating Mutation-Positive (EGFRm+) Advanced Non-Small-Cell Lung Cancer (NSCLC) Who Have Acquired Resistance to an EGFR Tyrosine Kinase Inhibitor (TKI) (NCT NCT02495233)
NCT ID: NCT02495233
Last Updated: 2024-11-27
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
10 participants
Primary outcome timeframe
Cycle 1 and Cycle ≥2 (up to 141 days)
Results posted on
2024-11-27
Participant Flow
Participants with Epidermal growth factor receptor (EGFR) activating mutation-positive (EGFRm+) advanced NSCLC who have acquired resistance to an EGFR Tyrosine kinase inhibitor (TKI) were enrolled in 4 study sites in Japan.
Eligible participants received gilteritinib in combination with erlotinib 150 mg. At least 3, and no more than 12, dose-limiting toxicity (DLT)-evaluable patients were to be enrolled in a given dose cohort. Dose escalation, cohort expansion or de-escalation decisions were to be guided by a modified toxicity probability interval design.
Participant milestones
| Measure |
Gilteritinib 120mg + Erlotinib 150mg
Gilteritinib was administered in combination with erlotinib orally once daily.
|
Gilteritinib 80mg+ Erlotinib 150mg
Gilteritinib was administered in combination with erlotinib orally once daily.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
7
|
|
Overall Study
COMPLETED
|
3
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Gilteritinib 120mg + Erlotinib 150mg
Gilteritinib was administered in combination with erlotinib orally once daily.
|
Gilteritinib 80mg+ Erlotinib 150mg
Gilteritinib was administered in combination with erlotinib orally once daily.
|
|---|---|---|
|
Overall Study
Miscellaneous
|
0
|
1
|
Baseline Characteristics
A Study of ASP2215 in Combination With Erlotinib in Subjects With Epidermal Growth Factor Receptor (EGFR) Activating Mutation-Positive (EGFRm+) Advanced Non-Small-Cell Lung Cancer (NSCLC) Who Have Acquired Resistance to an EGFR Tyrosine Kinase Inhibitor (TKI)
Baseline characteristics by cohort
| Measure |
Gilteritinib 120mg + Erlotinib 150mg
n=3 Participants
Gilteritinib was administered in combination with erlotinib orally once daily.
|
Gilteritinib 80mg+ Erlotinib 150mg
n=7 Participants
Gilteritinib was administered in combination with erlotinib orally once daily.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.3 year
STANDARD_DEVIATION 8.4 • n=99 Participants
|
61.4 year
STANDARD_DEVIATION 5.9 • n=107 Participants
|
64.1 year
STANDARD_DEVIATION 7.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 and Cycle ≥2 (up to 141 days)Population: Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs. DLT evaluable set (DES), was a subset of SAF and included participants who were either administered with at least 75% of planned dose during cycle 1 or experienced DLT during cycle 1.
Outcome measures
| Measure |
Gilteritinib 120mg + Erlotinib 150mg
n=3 Participants
Gilteritinib was administered in combination with erlotinib orally once daily.
|
Gilteritinib 80mg+ Erlotinib 150mg
n=6 Participants
Gilteritinib was administered in combination with erlotinib orally once daily.
|
|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLTs)
Cycle 1
|
2 Participants
|
2 Participants
|
|
Number of Participants With Dose Limiting Toxicities (DLTs)
Cycle ≥2
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)Population: SAF
Treatment-emergent adverse events (TEAE) was defined as an adverse event (AE) that started after administration of the study drugs and occurred within 30 days of the last dose of the study drugs. If a participant experienced an event both during the preinvestigational period and during the investigational period, the event was considered a TEAE only if it worsened in severity.
Outcome measures
| Measure |
Gilteritinib 120mg + Erlotinib 150mg
n=3 Participants
Gilteritinib was administered in combination with erlotinib orally once daily.
|
Gilteritinib 80mg+ Erlotinib 150mg
n=7 Participants
Gilteritinib was administered in combination with erlotinib orally once daily.
|
|---|---|---|
|
Number of Participants With Adverse Events
Any TEAEs
|
3 Participants
|
7 Participants
|
|
Number of Participants With Adverse Events
Drug-related TEAEs
|
3 Participants
|
7 Participants
|
|
Number of Participants With Adverse Events
TEAEs leading to death
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Serious TEAEs
|
2 Participants
|
3 Participants
|
|
Number of Participants With Adverse Events
Drug-related serious TEAEs
|
2 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events
TEAEs leading to withdrawal of treatment
|
2 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events
Drug-related TEAEs leading to withdrawal of treat.
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Days 1 and 28 of cycle 1Population: Pharmacokinetic Analysis Set (PKAS) consisted of all participants who received at least 1 dose of study drugs for whom sufficient plasma concentration data were available to facilitate derivation of at least 1 pharmacokinetic parameter and for whom the time of dosing on the day of sampling was known.
Outcome measures
| Measure |
Gilteritinib 120mg + Erlotinib 150mg
n=3 Participants
Gilteritinib was administered in combination with erlotinib orally once daily.
|
Gilteritinib 80mg+ Erlotinib 150mg
n=7 Participants
Gilteritinib was administered in combination with erlotinib orally once daily.
|
|---|---|---|
|
Area Under the Concentration-time Curve at 24 Hours (AUC24) for Gilteritinib
Cycle 1 Day 1
|
2950 h*ng/mL
Standard Deviation 1128
|
1885 h*ng/mL
Standard Deviation 685.6
|
|
Area Under the Concentration-time Curve at 24 Hours (AUC24) for Gilteritinib
Cycle 1 Day 28
|
12203 h*ng/mL
Standard Deviation NA
There was only 1 subject, the mean was the value for that 1 subject. The SD could not be calculated so NA would be entered.
|
8342 h*ng/mL
Standard Deviation 3023
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Days 1 and 28 of cycle 1Population: PKAS
Outcome measures
| Measure |
Gilteritinib 120mg + Erlotinib 150mg
n=3 Participants
Gilteritinib was administered in combination with erlotinib orally once daily.
|
Gilteritinib 80mg+ Erlotinib 150mg
n=7 Participants
Gilteritinib was administered in combination with erlotinib orally once daily.
|
|---|---|---|
|
Maximum Concentration (Cmax) for Gilteritinib
Cycle 1 Day 1
|
210.3 ng/mL
Standard Deviation 107.4
|
119 ng/mL
Standard Deviation 47.65
|
|
Maximum Concentration (Cmax) for Gilteritinib
Cycle 1 Day 28
|
637 ng/mL
Standard Deviation NA
There was only 1 subject, the mean was the value for that 1 subject. The SD could not be calculated so NA would be entered.
|
408.3 ng/mL
Standard Deviation 136.6
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Days 1 and 28 of cycle 1Population: PKAS
Outcome measures
| Measure |
Gilteritinib 120mg + Erlotinib 150mg
n=3 Participants
Gilteritinib was administered in combination with erlotinib orally once daily.
|
Gilteritinib 80mg+ Erlotinib 150mg
n=7 Participants
Gilteritinib was administered in combination with erlotinib orally once daily.
|
|---|---|---|
|
Time After Dosing When Cmax Occurs (Tmax) for Gilteritinib
Cycle 1 Day 1,
|
3.961 hr
Standard Deviation 0.08221
|
3.762 hr
Standard Deviation 0.8109
|
|
Time After Dosing When Cmax Occurs (Tmax) for Gilteritinib
Cycle 1 Day 28
|
2.00 hr
Standard Deviation NA
There was only 1 subject, the mean was the value for that 1 subject. The SD could not be calculated so NA would be entered.
|
4.594 hr
Standard Deviation 1.044
|
SECONDARY outcome
Timeframe: Predose on Day 1, 3, 8, 15, 22, 28 of cycle 1, Day 1 of cycle 3 and Day 1 of cycle 4Population: PKAS
All participants in Gilteritinib 120 mg + Erlotinib 150 mg group discontinued before cycle 3.
Outcome measures
| Measure |
Gilteritinib 120mg + Erlotinib 150mg
n=3 Participants
Gilteritinib was administered in combination with erlotinib orally once daily.
|
Gilteritinib 80mg+ Erlotinib 150mg
n=7 Participants
Gilteritinib was administered in combination with erlotinib orally once daily.
|
|---|---|---|
|
Concentration Immediately Prior to Dosing at Multiple Dosing (Ctrough) of Gilteritinib
Predose on Day 1 of cycle 1
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Concentration Immediately Prior to Dosing at Multiple Dosing (Ctrough) of Gilteritinib
Predose on Day 3 of cycle 1
|
112 ng/mL
Standard Deviation 21.7
|
110.2 ng/mL
Standard Deviation 46.51
|
|
Concentration Immediately Prior to Dosing at Multiple Dosing (Ctrough) of Gilteritinib
Predose on Day 8 of cycle 1
|
261.3 ng/mL
Standard Deviation 31.66
|
282.9 ng/mL
Standard Deviation 136.7
|
|
Concentration Immediately Prior to Dosing at Multiple Dosing (Ctrough) of Gilteritinib
Predose on Day 15 of cycle 1
|
491.7 ng/mL
Standard Deviation 430.5
|
397 ng/mL
Standard Deviation 208.9
|
|
Concentration Immediately Prior to Dosing at Multiple Dosing (Ctrough) of Gilteritinib
Predose on Day 22 of cycle 1
|
466.3 ng/mL
Standard Deviation 128.2
|
414.8 ng/mL
Standard Deviation 186.1
|
|
Concentration Immediately Prior to Dosing at Multiple Dosing (Ctrough) of Gilteritinib
Predose on Day 28 of cycle 1
|
430 ng/mL
Standard Deviation NA
There was only 1 subject, the mean was the value for that 1 subject. The SD could not be calculated so NA would be entered.
|
241.3 ng/mL
Standard Deviation 114.4
|
|
Concentration Immediately Prior to Dosing at Multiple Dosing (Ctrough) of Gilteritinib
Predose on Day 1 of cycle 3
|
—
|
161 ng/mL
Standard Deviation 38.18
|
|
Concentration Immediately Prior to Dosing at Multiple Dosing (Ctrough) of Gilteritinib
Predose on Day 1 of cycle 4
|
—
|
236 ng/mL
Standard Deviation 104.7
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Day 28 of cycle 1Population: PKAS
Outcome measures
| Measure |
Gilteritinib 120mg + Erlotinib 150mg
n=1 Participants
Gilteritinib was administered in combination with erlotinib orally once daily.
|
Gilteritinib 80mg+ Erlotinib 150mg
n=3 Participants
Gilteritinib was administered in combination with erlotinib orally once daily.
|
|---|---|---|
|
AUC24 of Erlotinib
|
34580 h*ng/mL
Standard Deviation NA
There was only 1 subject, the mean was the value for that 1 subject. The SD could not be calculated so NA would be entered.
|
54055 h*ng/mL
Standard Deviation 22962
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Day 28 of cycle 1Population: PKAS
Outcome measures
| Measure |
Gilteritinib 120mg + Erlotinib 150mg
n=1 Participants
Gilteritinib was administered in combination with erlotinib orally once daily.
|
Gilteritinib 80mg+ Erlotinib 150mg
n=3 Participants
Gilteritinib was administered in combination with erlotinib orally once daily.
|
|---|---|---|
|
Cmax of Erlotinib
|
3050 ng/mL
Standard Deviation NA
There was only 1 subject, the mean was the value for that 1 subject. The SD could not be calculated so NA would be entered.
|
3160 ng/mL
Standard Deviation 314.3
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Day 28 of cycle 1Population: PKAS
Outcome measures
| Measure |
Gilteritinib 120mg + Erlotinib 150mg
n=1 Participants
Gilteritinib was administered in combination with erlotinib orally once daily.
|
Gilteritinib 80mg+ Erlotinib 150mg
n=3 Participants
Gilteritinib was administered in combination with erlotinib orally once daily.
|
|---|---|---|
|
Tmax of Erlotinib
|
2.00 hr
Standard Deviation NA
There was only 1 subject, the mean was the value for that 1 subject. The SD could not be calculated so NA would be entered.
|
2.633 hr
Standard Deviation 1.185
|
SECONDARY outcome
Timeframe: Day 8, 15, 22, 28 of cycle 1Population: PKAS
Outcome measures
| Measure |
Gilteritinib 120mg + Erlotinib 150mg
n=3 Participants
Gilteritinib was administered in combination with erlotinib orally once daily.
|
Gilteritinib 80mg+ Erlotinib 150mg
n=7 Participants
Gilteritinib was administered in combination with erlotinib orally once daily.
|
|---|---|---|
|
Ctrough of Erlotinib
Predose of Day 8 of cycle 1
|
1004 ng/mL
Standard Deviation 758.7
|
1827 ng/mL
Standard Deviation 1392
|
|
Ctrough of Erlotinib
Predose of Day 15 of cycle 1
|
1427 ng/mL
Standard Deviation 1596
|
2098 ng/mL
Standard Deviation 1637
|
|
Ctrough of Erlotinib
Predose of Day 22 of cycle 1
|
942.7 ng/mL
Standard Deviation 116
|
1999 ng/mL
Standard Deviation 1285
|
|
Ctrough of Erlotinib
Predose of Day 28 of cycle 1
|
909 ng/mL
Standard Deviation NA
There was only 1 subject, the mean was the value for that 1 subject. The SD could not be calculated so NA would be entered.
|
1368 ng/mL
Standard Deviation 1255
|
SECONDARY outcome
Timeframe: End of treatment (approximately 4 months)Population: ASAT consisted of all participants allocated to treatment.
ORR was defined as Objective Response Rate (ORR) was the proportion of patients whose best overall response was complete response (CR) or partial response (PR) per RECIST version 1.1. Only patients with measurable disease at baseline were to be included in the analysis of ORR.
Outcome measures
| Measure |
Gilteritinib 120mg + Erlotinib 150mg
n=3 Participants
Gilteritinib was administered in combination with erlotinib orally once daily.
|
Gilteritinib 80mg+ Erlotinib 150mg
n=6 Participants
Gilteritinib was administered in combination with erlotinib orally once daily.
|
|---|---|---|
|
Objective Response Rate (ORR) in Phase 1b
|
0 percentage of participants
|
0 percentage of participants
|
Adverse Events
Gilteritinib 120mg + Erlotinib 150mg
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Gilteritinib 80mg+ Erlotinib 150mg
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gilteritinib 120mg + Erlotinib 150mg
n=3 participants at risk
Gilteritinib was administered in combination with erlotinib orally once daily.
|
Gilteritinib 80mg+ Erlotinib 150mg
n=7 participants at risk
Gilteritinib was administered in combination with erlotinib orally once daily.
|
|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
66.7%
2/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
28.6%
2/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Investigations
Aspartate aminotransferase increased
|
66.7%
2/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
14.3%
1/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
14.3%
1/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Renal and urinary disorders
Renal failure acute
|
33.3%
1/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
14.3%
1/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
Other adverse events
| Measure |
Gilteritinib 120mg + Erlotinib 150mg
n=3 participants at risk
Gilteritinib was administered in combination with erlotinib orally once daily.
|
Gilteritinib 80mg+ Erlotinib 150mg
n=7 participants at risk
Gilteritinib was administered in combination with erlotinib orally once daily.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Dry skin
|
66.7%
2/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
14.3%
1/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
28.6%
2/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
1/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
14.3%
1/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Infections and infestations
Paronychia
|
33.3%
1/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
28.6%
2/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Infections and infestations
Acne pustular
|
0.00%
0/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
14.3%
1/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
14.3%
1/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Infections and infestations
Cystitis
|
33.3%
1/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Infections and infestations
Gastroenteritis staphylococcal
|
33.3%
1/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Infections and infestations
Pharyngitis
|
33.3%
1/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
14.3%
1/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
42.9%
3/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
66.7%
2/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
14.3%
1/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
28.6%
2/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Nervous system disorders
Dysgeusia
|
33.3%
1/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
14.3%
1/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
33.3%
1/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
14.3%
1/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
14.3%
1/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
33.3%
1/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
14.3%
1/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
14.3%
1/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
14.3%
1/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
14.3%
1/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
14.3%
1/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
General disorders
Malaise
|
66.7%
2/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
General disorders
Fatigue
|
0.00%
0/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
14.3%
1/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
14.3%
1/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
14.3%
1/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
14.3%
1/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Gastrointestinal disorders
Diarrhoea
|
100.0%
3/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
57.1%
4/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Gastrointestinal disorders
Constipation
|
100.0%
3/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
28.6%
2/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
14.3%
1/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Gastrointestinal disorders
Stomatitis
|
33.3%
1/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
14.3%
1/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
33.3%
1/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
14.3%
1/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
14.3%
1/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Gastrointestinal disorders
Enteritis
|
33.3%
1/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Gastrointestinal disorders
Gastric disorder
|
33.3%
1/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Gastrointestinal disorders
Haemorrhoids
|
33.3%
1/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
0.00%
0/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
14.3%
1/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
14.3%
1/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
14.3%
1/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Investigations
Alanine aminotransferase increased
|
66.7%
2/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
57.1%
4/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
71.4%
5/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Investigations
Blood creatine phosphokinase increased
|
66.7%
2/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
42.9%
3/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
42.9%
3/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Investigations
Blood creatinine increased
|
33.3%
1/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
14.3%
1/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
28.6%
2/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Investigations
Aldolase increased
|
0.00%
0/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
14.3%
1/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Investigations
Amylase increased
|
0.00%
0/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
14.3%
1/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Investigations
Electrocardiogram QT prolonged
|
33.3%
1/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Investigations
Myoglobin blood increased
|
0.00%
0/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
14.3%
1/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Investigations
Platelet count decreased
|
33.3%
1/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Investigations
Weight decreased
|
0.00%
0/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
14.3%
1/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
66.7%
2/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
85.7%
6/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
1/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
14.3%
1/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
14.3%
1/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
33.3%
1/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
28.6%
2/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
28.6%
2/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
14.3%
1/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Vascular disorders
Hypertension
|
33.3%
1/3 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/7 • From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
|
Additional Information
Clinical Trial Disclosure
Astellas Pharma Global Development, Inc.
Phone: 800-888-7704
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.
- Publication restrictions are in place
Restriction type: OTHER