Trial Outcomes & Findings for A Study of Niraparib as Single Agent in Participants With Advanced Solid Tumors (NCT NCT03497429)
NCT ID: NCT03497429
Last Updated: 2021-11-09
Results Overview
DLT was evaluated as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), v4.03 and defined as any of the following events occurring during Cycle 1 that were considered by investigator to be related with niraparib: Any Grade 5 or 4 hematologic toxicity, except Grade 4 neutropenia less than (\<) 7 days; Grade 3 or 4 neutropenia with fever greater than (\>) 38.5 degree Celsius and/or infection requiring antibiotic/anti-fungal treatment; Any Grade 3, 4,or 5 non-hematologic toxicity except: Grade 3 nausea, vomiting, diarrhea/dehydration occurring in setting of inadequate compliance with supportive care and lasting \<48 hours, Inadequately treated hypersensitivity reactions, Grade 3 acidosis/alkalosis that responded to intervention by improving to less than or equal to (\<=) Grade 2 within 48 hours, Isolated asymptomatic Grade 3 amylase elevation, hypercholesterolemia and hypertriglyceridemia; Any TEAE leading to an interruption of niraparib for \>14 days.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
9 participants
Primary outcome timeframe
Baseline up to Day 21 in Cycle 1 (Cycle length=21 days)
Results posted on
2021-11-09
Participant Flow
Participants took part in the study at 1 investigative site in Japan from 5 April 2018 to 10 February 2020.
Japanese participants with advanced solid tumors were enrolled in this dose-escalation study to receive niraparib 200 milligram (mg) in Cohort 1 and niraparib 300 mg in Cohort 2.
Participant milestones
| Measure |
Cohort 1: Niraparib 200 mg
Niraparib 200 mg, capsule, orally, once daily, in each 21-day treatment cycle until objective disease progression, unacceptable toxicity or until study discontinuation due to any other reasons.
|
Cohort 2: Niraparib 300 mg
Niraparib 300 mg, capsule, orally, once daily, in each 21-day treatment cycle until objective disease progression, unacceptable toxicity or until study discontinuation due to any other reasons.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
6
|
|
Overall Study
Started
|
3
|
6
|
|
Overall Study
Completed
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
Reasons for withdrawal
| Measure |
Cohort 1: Niraparib 200 mg
Niraparib 200 mg, capsule, orally, once daily, in each 21-day treatment cycle until objective disease progression, unacceptable toxicity or until study discontinuation due to any other reasons.
|
Cohort 2: Niraparib 300 mg
Niraparib 300 mg, capsule, orally, once daily, in each 21-day treatment cycle until objective disease progression, unacceptable toxicity or until study discontinuation due to any other reasons.
|
|---|---|---|
|
Overall Study
Progressive disease
|
3
|
4
|
|
Overall Study
Adverse Event
|
0
|
2
|
Baseline Characteristics
A Study of Niraparib as Single Agent in Participants With Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
Cohort 1: Niraparib 200 mg
n=3 Participants
Niraparib 200 mg, capsule, orally, once daily, in each 21-day treatment cycle until objective disease progression, unacceptable toxicity or until study discontinuation due to any other reasons.
|
Cohort 2: Niraparib 300 mg
n=6 Participants
Niraparib 300 mg, capsule, orally, once daily, in each 21-day treatment cycle until objective disease progression, unacceptable toxicity or until study discontinuation due to any other reasons.
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.0 years
STANDARD_DEVIATION 13.75 • n=5 Participants
|
61.3 years
STANDARD_DEVIATION 12.99 • n=7 Participants
|
58.6 years
STANDARD_DEVIATION 13.04 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Height
|
166.7 centimeter (cm)
STANDARD_DEVIATION 2.08 • n=5 Participants
|
164.0 centimeter (cm)
STANDARD_DEVIATION 7.64 • n=7 Participants
|
164.9 centimeter (cm)
STANDARD_DEVIATION 6.27 • n=5 Participants
|
|
Weight
|
65.57 kilogram (kg)
STANDARD_DEVIATION 8.976 • n=5 Participants
|
64.23 kilogram (kg)
STANDARD_DEVIATION 6.575 • n=7 Participants
|
64.68 kilogram (kg)
STANDARD_DEVIATION 6.900 • n=5 Participants
|
|
Body Mass Index (BMI)
|
23.56 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.614 • n=5 Participants
|
23.89 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 1.887 • n=7 Participants
|
23.78 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 1.990 • n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Diagnosis
Pancreatic Cancer
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Diagnosis
Other
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Prior Surgery/Procedure
Had prior surgery/procedure
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Prior Surgery/Procedure
Did not have surgery/procedure
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Prior Radiation Therapy
Had prior radiation therapy
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Prior Radiation Therapy
Did not have prior radiation therapy
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Breast Cancer Susceptibility Gene 1 (BRCA1) Mutant
Had BRCA1 mutant
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Breast Cancer Susceptibility Gene 1 (BRCA1) Mutant
Did not have BRCA1 mutant
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Breast Cancer Susceptibility Gene 1 (BRCA1) Mutant
Unknown
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Breast Cancer Susceptibility Gene 2 (BRCA2) Mutant
Had BRCA2 mutant
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Breast Cancer Susceptibility Gene 2 (BRCA2) Mutant
Did not have BRCA2 mutant
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Breast Cancer Susceptibility Gene 2 (BRCA2) Mutant
Unknown
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 21 in Cycle 1 (Cycle length=21 days)Population: The DLT-evaluable set included participants who had received at least 80 percent (%) of planned doses of niraparib in Cycle 1 (for at least 17 days out of 21 days) unless interrupted by study drug-related toxicities and had sufficient follow-up data considered by sponsor and investigator to determine whether DLT occurred.
DLT was evaluated as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), v4.03 and defined as any of the following events occurring during Cycle 1 that were considered by investigator to be related with niraparib: Any Grade 5 or 4 hematologic toxicity, except Grade 4 neutropenia less than (\<) 7 days; Grade 3 or 4 neutropenia with fever greater than (\>) 38.5 degree Celsius and/or infection requiring antibiotic/anti-fungal treatment; Any Grade 3, 4,or 5 non-hematologic toxicity except: Grade 3 nausea, vomiting, diarrhea/dehydration occurring in setting of inadequate compliance with supportive care and lasting \<48 hours, Inadequately treated hypersensitivity reactions, Grade 3 acidosis/alkalosis that responded to intervention by improving to less than or equal to (\<=) Grade 2 within 48 hours, Isolated asymptomatic Grade 3 amylase elevation, hypercholesterolemia and hypertriglyceridemia; Any TEAE leading to an interruption of niraparib for \>14 days.
Outcome measures
| Measure |
Cohort 1: Niraparib 200 mg
n=3 Participants
Niraparib 200 mg, capsule, orally, once daily, in each 21-day treatment cycle until objective disease progression, unacceptable toxicity or until study discontinuation due to any other reasons.
|
Cohort 2: Niraparib 300 mg
n=6 Participants
Niraparib 300 mg, capsule, orally, once daily, in each 21-day treatment cycle until objective disease progression, unacceptable toxicity or until study discontinuation due to any other reasons.
|
|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLTs)
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)Population: The safety analysis set included participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Cohort 1: Niraparib 200 mg
n=3 Participants
Niraparib 200 mg, capsule, orally, once daily, in each 21-day treatment cycle until objective disease progression, unacceptable toxicity or until study discontinuation due to any other reasons.
|
Cohort 2: Niraparib 300 mg
n=6 Participants
Niraparib 300 mg, capsule, orally, once daily, in each 21-day treatment cycle until objective disease progression, unacceptable toxicity or until study discontinuation due to any other reasons.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
|
3 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: From the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)Population: The safety analysis set included participants who received at least 1 dose of study drug.
TEAEs were graded as per the NCI-CTCAE version 4.03. As per the NCI-CTCAE, Grade 1 (mild, asymptomatic or mild symptoms); Grade 2 (moderate, minimal, local or noninvasive intervention indicated); Grade 3 (severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated); Grade 4 (life-threatening consequences, urgent intervention indicated); Grade 5 (death related to adverse event \[AE\]).
Outcome measures
| Measure |
Cohort 1: Niraparib 200 mg
n=3 Participants
Niraparib 200 mg, capsule, orally, once daily, in each 21-day treatment cycle until objective disease progression, unacceptable toxicity or until study discontinuation due to any other reasons.
|
Cohort 2: Niraparib 300 mg
n=6 Participants
Niraparib 300 mg, capsule, orally, once daily, in each 21-day treatment cycle until objective disease progression, unacceptable toxicity or until study discontinuation due to any other reasons.
|
|---|---|---|
|
Number of Participants With Grade 3 or Higher TEAEs
|
1 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: From the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)Population: The safety analysis set included participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Cohort 1: Niraparib 200 mg
n=3 Participants
Niraparib 200 mg, capsule, orally, once daily, in each 21-day treatment cycle until objective disease progression, unacceptable toxicity or until study discontinuation due to any other reasons.
|
Cohort 2: Niraparib 300 mg
n=6 Participants
Niraparib 300 mg, capsule, orally, once daily, in each 21-day treatment cycle until objective disease progression, unacceptable toxicity or until study discontinuation due to any other reasons.
|
|---|---|---|
|
Number of Participants With Serious TEAEs
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)Population: The safety analysis set included participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Cohort 1: Niraparib 200 mg
n=3 Participants
Niraparib 200 mg, capsule, orally, once daily, in each 21-day treatment cycle until objective disease progression, unacceptable toxicity or until study discontinuation due to any other reasons.
|
Cohort 2: Niraparib 300 mg
n=6 Participants
Niraparib 300 mg, capsule, orally, once daily, in each 21-day treatment cycle until objective disease progression, unacceptable toxicity or until study discontinuation due to any other reasons.
|
|---|---|---|
|
Number of Participants Who Discontinued Study Drug Due to TEAEs
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Cycle 1 Days 1 and 21: pre-dose and at multiple time points (up to 24 hours) post-dose (Cycle length =21 days)Population: The pharmacokinetic (PK) analysis set included participants with sufficient dosing and PK data to reliably estimate 1 or more PK parameters. Here "number analyzed" were participants who were evaluable for the outcome measure at given time points.
Outcome measures
| Measure |
Cohort 1: Niraparib 200 mg
n=3 Participants
Niraparib 200 mg, capsule, orally, once daily, in each 21-day treatment cycle until objective disease progression, unacceptable toxicity or until study discontinuation due to any other reasons.
|
Cohort 2: Niraparib 300 mg
n=6 Participants
Niraparib 300 mg, capsule, orally, once daily, in each 21-day treatment cycle until objective disease progression, unacceptable toxicity or until study discontinuation due to any other reasons.
|
|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for Niraparib
Cycle 1 Day 1
|
442.9 nanogram per milliliter (ng/mL)
Standard Deviation 195.09
|
529.6 nanogram per milliliter (ng/mL)
Standard Deviation 149.22
|
|
Cmax: Maximum Observed Plasma Concentration for Niraparib
Cycle 1 Day 21
|
729.2 nanogram per milliliter (ng/mL)
Standard Deviation 387.50
|
1167 nanogram per milliliter (ng/mL)
Standard Deviation 194.94
|
SECONDARY outcome
Timeframe: Cycle 1 Days 1 and 21: pre-dose and at multiple time points (up to 24 hours) post-dose (Cycle length =21 days)Population: The PK analysis set included participants with sufficient dosing and PK data to reliably estimate 1 or more PK parameters. Here "number analyzed" were participants who were evaluable for the outcome measure at given time points.
Outcome measures
| Measure |
Cohort 1: Niraparib 200 mg
n=3 Participants
Niraparib 200 mg, capsule, orally, once daily, in each 21-day treatment cycle until objective disease progression, unacceptable toxicity or until study discontinuation due to any other reasons.
|
Cohort 2: Niraparib 300 mg
n=6 Participants
Niraparib 300 mg, capsule, orally, once daily, in each 21-day treatment cycle until objective disease progression, unacceptable toxicity or until study discontinuation due to any other reasons.
|
|---|---|---|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Niraparib
Cycle 1 Day 1
|
4.000 hours
Interval 1.52 to 4.07
|
4.035 hours
Interval 2.05 to 10.2
|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Niraparib
Cycle 1 Day 21
|
3.950 hours
Interval 3.83 to 4.03
|
2.890 hours
Interval 2.88 to 6.0
|
SECONDARY outcome
Timeframe: Cycle 1 Days 1 and 21: pre-dose and at multiple time points (up to 24 hours) post-dose (Cycle length =21 days)Population: The PK analysis set included participants with sufficient dosing and PK data to reliably estimate 1 or more PK parameters. Here "number analyzed" were participants who were evaluable for the outcome measure at given time points.
Outcome measures
| Measure |
Cohort 1: Niraparib 200 mg
n=3 Participants
Niraparib 200 mg, capsule, orally, once daily, in each 21-day treatment cycle until objective disease progression, unacceptable toxicity or until study discontinuation due to any other reasons.
|
Cohort 2: Niraparib 300 mg
n=6 Participants
Niraparib 300 mg, capsule, orally, once daily, in each 21-day treatment cycle until objective disease progression, unacceptable toxicity or until study discontinuation due to any other reasons.
|
|---|---|---|
|
AUC24：Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours for Niraparib
Cycle 1 Day 1
|
4931 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 2905.0
|
6270 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 2631.2
|
|
AUC24：Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours for Niraparib
Cycle 1 Day 21
|
13040 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 6493.3
|
19540 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 3117.2
|
Adverse Events
Cohort 1: Niraparib 200 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 2: Niraparib 300 mg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: Niraparib 200 mg
n=3 participants at risk
Niraparib 200 mg, capsule, orally, once daily, in each 21-day treatment cycle until objective disease progression, unacceptable toxicity or until study discontinuation due to any other reasons.
|
Cohort 2: Niraparib 300 mg
n=6 participants at risk
Niraparib 300 mg, capsule, orally, once daily, in each 21-day treatment cycle until objective disease progression, unacceptable toxicity or until study discontinuation due to any other reasons.
|
|---|---|---|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/3 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Other adverse events
| Measure |
Cohort 1: Niraparib 200 mg
n=3 participants at risk
Niraparib 200 mg, capsule, orally, once daily, in each 21-day treatment cycle until objective disease progression, unacceptable toxicity or until study discontinuation due to any other reasons.
|
Cohort 2: Niraparib 300 mg
n=6 participants at risk
Niraparib 300 mg, capsule, orally, once daily, in each 21-day treatment cycle until objective disease progression, unacceptable toxicity or until study discontinuation due to any other reasons.
|
|---|---|---|
|
Investigations
Blood alkaline phosphatase increased
|
33.3%
1/3 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
66.7%
4/6 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
3/6 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
3/6 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
66.7%
4/6 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
2/3 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
2/6 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
2/6 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
2/6 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Fatigue
|
66.7%
2/3 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Malaise
|
33.3%
1/3 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
2/6 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Chest pain
|
0.00%
0/3 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
2/6 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Oedema peripheral
|
33.3%
1/3 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/3 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
33.3%
1/3 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Skin wound
|
0.00%
0/3 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Platelet count decreased
|
33.3%
1/3 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
83.3%
5/6 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
83.3%
5/6 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/3 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
3/6 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood creatinine increased
|
33.3%
1/3 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
White blood cell count decreased
|
33.3%
1/3 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Electrocardiogram QT prolonged
|
33.3%
1/3 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Neutrophil count decreased
|
33.3%
1/3 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Weight decreased
|
0.00%
0/3 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
66.7%
2/3 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
2/6 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/3 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
33.3%
1/3 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Hallucination
|
33.3%
1/3 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
33.3%
1/3 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
33.3%
1/3 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
2/6 • Treatment-emergent adverse events were adverse events that started from the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
- Publication restrictions are in place
Restriction type: OTHER