Trial Outcomes & Findings for A Study to Evaluate the Effects of Rifampin on Pharmacokinetics (PK) of Pevonedistat in Participants With Advanced Solid Tumors (NCT NCT03486314)
NCT ID: NCT03486314
Last Updated: 2022-04-18
Results Overview
The Least square (LS) means ratio of Day 10 over Day 1 were calculated from a mixed-model analysis of variance model.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
20 participants
Primary outcome timeframe
Days 1 and 10 pre-dose and at multiple time points (up to 48 hours) post-dose
Results posted on
2022-04-18
Participant Flow
Participants took part in the study at 4 investigative sites in the United States from 13 August 2018 to 28 February 2021.
Participants with histologically or cytologically confirmed metastatic or locally advanced solid tumor were enrolled in this 2-part study to receive intravenous infusion of pevonedistat along with rifampin capsule in Part A and pevonedistat in combination with chemotherapy agents in Part B (optional part). After completion of Part A, participants had an opportunity to continue into optional Part B.
Participant milestones
| Measure |
Part A: Pevonedistat 50 mg/m^2 + Rifampin 600 mg
Pevonedistat 50 milligram per square meter (mg/m\^2), infusion, intravenously, once on Days 1 and 10, and then rifampin 600 milligram (mg), capsule, orally, once daily from Day 3 up to Day 11 in Part A. Pevonedistat was not administered from Day 2 through Day 9.
|
Part B: Pevonedistat 25 mg/m^2 + Docetaxel 75 mg/m^2
Pevonedistat 25 mg/m\^2, infusion, intravenously in combination with docetaxel 75 mg/m\^2, infusion, intravenously on Day 1 of 21-day cycle, followed by pevonedistat 25 mg/m\^2, infusion, intravenously alone once on Days 3 and 5 in each 21-day cycle for up to 17 cycles or symptomatic deterioration or disease progression, treatment discontinuation for another reason, or until the study was stopped in Part B. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
|
Part B: Pevonedistat 20 mg/m^2 + Carboplatin AUC5+ Paclitaxel 175 mg/m^2
Pevonedistat 20 mg/m\^2, infusion, intravenously in combination with carboplatin area under the plasma concentration (AUC) at the dose of 5 milligram\* minute per milliliter (mg\*min/mL), infusion, intravenously and paclitaxel 175 mg/m\^2, infusion, intravenously, once on Day 1 of 21-day cycle, followed by pevonedistat 20 mg/m\^2, infusion, intravenously alone once on Days 3 and 5 in each 21-day cycle for up to 17 cycles or symptomatic deterioration or disease progression, treatment was discontinued for another reason, or until the study was stopped in Part B. Pevonedistat was administered after the paclitaxel and carboplatin chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
|
|---|---|---|---|
|
Part A
STARTED
|
20
|
0
|
0
|
|
Part A
COMPLETED
|
17
|
0
|
0
|
|
Part A
NOT COMPLETED
|
3
|
0
|
0
|
|
Part B
STARTED
|
0
|
9
|
8
|
|
Part B
COMPLETED
|
0
|
9
|
8
|
|
Part B
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part A: Pevonedistat 50 mg/m^2 + Rifampin 600 mg
Pevonedistat 50 milligram per square meter (mg/m\^2), infusion, intravenously, once on Days 1 and 10, and then rifampin 600 milligram (mg), capsule, orally, once daily from Day 3 up to Day 11 in Part A. Pevonedistat was not administered from Day 2 through Day 9.
|
Part B: Pevonedistat 25 mg/m^2 + Docetaxel 75 mg/m^2
Pevonedistat 25 mg/m\^2, infusion, intravenously in combination with docetaxel 75 mg/m\^2, infusion, intravenously on Day 1 of 21-day cycle, followed by pevonedistat 25 mg/m\^2, infusion, intravenously alone once on Days 3 and 5 in each 21-day cycle for up to 17 cycles or symptomatic deterioration or disease progression, treatment discontinuation for another reason, or until the study was stopped in Part B. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
|
Part B: Pevonedistat 20 mg/m^2 + Carboplatin AUC5+ Paclitaxel 175 mg/m^2
Pevonedistat 20 mg/m\^2, infusion, intravenously in combination with carboplatin area under the plasma concentration (AUC) at the dose of 5 milligram\* minute per milliliter (mg\*min/mL), infusion, intravenously and paclitaxel 175 mg/m\^2, infusion, intravenously, once on Day 1 of 21-day cycle, followed by pevonedistat 20 mg/m\^2, infusion, intravenously alone once on Days 3 and 5 in each 21-day cycle for up to 17 cycles or symptomatic deterioration or disease progression, treatment was discontinued for another reason, or until the study was stopped in Part B. Pevonedistat was administered after the paclitaxel and carboplatin chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
|
|---|---|---|---|
|
Part A
Adverse Event
|
1
|
0
|
0
|
|
Part A
Symptomatic Deterioration
|
2
|
0
|
0
|
Baseline Characteristics
A Study to Evaluate the Effects of Rifampin on Pharmacokinetics (PK) of Pevonedistat in Participants With Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
Part A: Pevonedistat 50 mg/m^2 + Rifampin 600 mg
n=20 Participants
Pevonedistat 50 mg/m\^2, infusion, intravenously, once on Days 1 and 10, and then rifampin 600 mg, capsule, orally, once daily from Day 3 up to Day 11 in Part A. Pevonedistat was not administered from Day 2 through Day 9.
|
|---|---|
|
Age, Continuous
|
64.9 years
STANDARD_DEVIATION 8.70 • n=93 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=93 Participants
|
|
Height
|
171.91 centimeter (cm)
STANDARD_DEVIATION 10.235 • n=93 Participants
|
|
Weight
|
87.13 kilogram (kg)
STANDARD_DEVIATION 22.667 • n=93 Participants
|
|
Body Surface Area (BSA)
|
2.03 square meter (m^2)
STANDARD_DEVIATION 0.307 • n=93 Participants
|
PRIMARY outcome
Timeframe: Days 1 and 10 pre-dose and at multiple time points (up to 48 hours) post-dosePopulation: The pharmacokinetic (PK) evaluable population was defined as all enrolled participants who a) received the protocol specified single pevonedistat dose in Part A; b) did not receive any excluded medications throughout the completion of Part A; and c) had sufficient concentration-time data to permit reliable estimation of PK parameters. As planned, this outcome measure was only assessed in Part A. Here "overall number of participants" analyzed are those who were evaluable for this outcome measure.
The Least square (LS) means ratio of Day 10 over Day 1 were calculated from a mixed-model analysis of variance model.
Outcome measures
| Measure |
Part A: Pevonedistat 50 mg/m^2 + Rifampin 600 mg
n=17 Participants
Pevonedistat 50 mg/m\^2, infusion, intravenously, once on Days 1 and 10, and then rifampin 600 mg, capsule, orally, once daily from Day 3 up to Day 11 in Part A. Pevonedistat was not administered from Day 2 through Day 9.
|
Part B: Pevonedistat 20 mg/m^2 + Carboplatin AUC5 + Paclitaxel 175 mg/m^2
Pevonedistat 20 mg/m\^2, infusion, intravenously in combination with carboplatin AUC at the dose of 5 mg\*min/mL, infusion, intravenously and paclitaxel 175 mg/m\^2, infusion, intravenously, once on Day 1 of 21-day cycle, followed by pevonedistat 20 mg/m\^2, infusion, intravenously alone once on Days 3 and 5 in each 21-day cycle for up to 17 cycles or symptomatic deterioration or disease progression, treatment was discontinued for another reason, or until the study was stopped in Part B. Pevonedistat was administered after the paclitaxel and carboplatin chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
|
|---|---|---|
|
Part A: Ratio of Maximum Observed Plasma Concentration (Cmax) for Pevonedistat Without Rifampin (Day 1) and With Rifampin (Day 10)
|
0.962 ratio
Interval 0.792 to 1.168
|
—
|
PRIMARY outcome
Timeframe: Days 1 and 10 pre-dose and at multiple time points (up to 48 hours) post-dosePopulation: The PK-evaluable population was defined as all enrolled participants who a) received the protocol specified single pevonedistat dose in Part A; b) did not receive any excluded medications throughout the completion of Part A; and c) had sufficient concentration-time data to permit reliable estimation of PK parameters. As planned, this outcome measure was only assessed in Part A. Here "overall number of participants" analyzed are those who were evaluable for this outcome measure.
The LS means ratio of Day 10 over Day 1 were calculated from a mixed-model analysis of variance model.
Outcome measures
| Measure |
Part A: Pevonedistat 50 mg/m^2 + Rifampin 600 mg
n=17 Participants
Pevonedistat 50 mg/m\^2, infusion, intravenously, once on Days 1 and 10, and then rifampin 600 mg, capsule, orally, once daily from Day 3 up to Day 11 in Part A. Pevonedistat was not administered from Day 2 through Day 9.
|
Part B: Pevonedistat 20 mg/m^2 + Carboplatin AUC5 + Paclitaxel 175 mg/m^2
Pevonedistat 20 mg/m\^2, infusion, intravenously in combination with carboplatin AUC at the dose of 5 mg\*min/mL, infusion, intravenously and paclitaxel 175 mg/m\^2, infusion, intravenously, once on Day 1 of 21-day cycle, followed by pevonedistat 20 mg/m\^2, infusion, intravenously alone once on Days 3 and 5 in each 21-day cycle for up to 17 cycles or symptomatic deterioration or disease progression, treatment was discontinued for another reason, or until the study was stopped in Part B. Pevonedistat was administered after the paclitaxel and carboplatin chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
|
|---|---|---|
|
Part A: Ratio of Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for Pevonedistat Without Rifampin (Day 1) and With Rifampin (Day 10)
|
0.785 ratio
Interval 0.684 to 0.901
|
—
|
PRIMARY outcome
Timeframe: Days 1 and 10 pre-dose and at multiple time points (up to 48 hours) post-dosePopulation: The PK-evaluable population was defined as all enrolled participants who a) received the protocol specified single pevonedistat dose in Part A; b) did not receive any excluded medications throughout the completion of Part A; and c) had sufficient concentration-time data to permit reliable estimation of PK parameters. As planned, this outcome measure was only assessed in Part A. Here "overall number of participants" analyzed are those who were evaluable for this outcome measure.
The LS means ratio of Day 10 over Day 1 were calculated from a mixed-model analysis of variance model.
Outcome measures
| Measure |
Part A: Pevonedistat 50 mg/m^2 + Rifampin 600 mg
n=17 Participants
Pevonedistat 50 mg/m\^2, infusion, intravenously, once on Days 1 and 10, and then rifampin 600 mg, capsule, orally, once daily from Day 3 up to Day 11 in Part A. Pevonedistat was not administered from Day 2 through Day 9.
|
Part B: Pevonedistat 20 mg/m^2 + Carboplatin AUC5 + Paclitaxel 175 mg/m^2
Pevonedistat 20 mg/m\^2, infusion, intravenously in combination with carboplatin AUC at the dose of 5 mg\*min/mL, infusion, intravenously and paclitaxel 175 mg/m\^2, infusion, intravenously, once on Day 1 of 21-day cycle, followed by pevonedistat 20 mg/m\^2, infusion, intravenously alone once on Days 3 and 5 in each 21-day cycle for up to 17 cycles or symptomatic deterioration or disease progression, treatment was discontinued for another reason, or until the study was stopped in Part B. Pevonedistat was administered after the paclitaxel and carboplatin chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
|
|---|---|---|
|
Part A: Ratio of Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC∞) for Pevonedistat Without Rifampin (Day 1) and With Rifampin (Day 10)
|
0.790 ratio
Interval 0.692 to 0.902
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 10 pre-dose and at multiple time points (up to 48 hours) post-dosePopulation: The PK-evaluable population was defined as all enrolled participants who a) received the protocol specified single pevonedistat dose in Part A; b) did not receive any excluded medications throughout the completion of Part A; and c) had sufficient concentration-time data to permit reliable estimation of PK parameters. As planned, this outcome measure was only assessed in Part A. Here number analyzed "n" signifies participants who were evaluable for this outcome measure at given time points.
Outcome measures
| Measure |
Part A: Pevonedistat 50 mg/m^2 + Rifampin 600 mg
n=20 Participants
Pevonedistat 50 mg/m\^2, infusion, intravenously, once on Days 1 and 10, and then rifampin 600 mg, capsule, orally, once daily from Day 3 up to Day 11 in Part A. Pevonedistat was not administered from Day 2 through Day 9.
|
Part B: Pevonedistat 20 mg/m^2 + Carboplatin AUC5 + Paclitaxel 175 mg/m^2
Pevonedistat 20 mg/m\^2, infusion, intravenously in combination with carboplatin AUC at the dose of 5 mg\*min/mL, infusion, intravenously and paclitaxel 175 mg/m\^2, infusion, intravenously, once on Day 1 of 21-day cycle, followed by pevonedistat 20 mg/m\^2, infusion, intravenously alone once on Days 3 and 5 in each 21-day cycle for up to 17 cycles or symptomatic deterioration or disease progression, treatment was discontinued for another reason, or until the study was stopped in Part B. Pevonedistat was administered after the paclitaxel and carboplatin chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
|
|---|---|---|
|
Part A: Total Clearance After Intravenous Administration (CL) for Pevonedistat Without Rifampin (Day 1) and With Rifampin (Day 10)
Pevonedistat without rifampin (Day 1)
|
35.22 liter per hour (L/h)
Standard Deviation 10.980
|
—
|
|
Part A: Total Clearance After Intravenous Administration (CL) for Pevonedistat Without Rifampin (Day 1) and With Rifampin (Day 10)
Pevonedistat with rifampin (Day 10)
|
43.77 liter per hour (L/h)
Standard Deviation 12.604
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 10 pre-dose and at multiple time points (up to 48 hours) post-dosePopulation: The PK-evaluable population was defined as all enrolled participants who a) received the protocol specified single pevonedistat dose in Part A; b) did not receive any excluded medications throughout the completion of Part A; and c) had sufficient concentration-time data to permit reliable estimation of PK parameters. As planned, this outcome measure was only assessed in Part A. Here number analyzed "n" signifies participants who were evaluable for this outcome measure at given time points.
Outcome measures
| Measure |
Part A: Pevonedistat 50 mg/m^2 + Rifampin 600 mg
n=20 Participants
Pevonedistat 50 mg/m\^2, infusion, intravenously, once on Days 1 and 10, and then rifampin 600 mg, capsule, orally, once daily from Day 3 up to Day 11 in Part A. Pevonedistat was not administered from Day 2 through Day 9.
|
Part B: Pevonedistat 20 mg/m^2 + Carboplatin AUC5 + Paclitaxel 175 mg/m^2
Pevonedistat 20 mg/m\^2, infusion, intravenously in combination with carboplatin AUC at the dose of 5 mg\*min/mL, infusion, intravenously and paclitaxel 175 mg/m\^2, infusion, intravenously, once on Day 1 of 21-day cycle, followed by pevonedistat 20 mg/m\^2, infusion, intravenously alone once on Days 3 and 5 in each 21-day cycle for up to 17 cycles or symptomatic deterioration or disease progression, treatment was discontinued for another reason, or until the study was stopped in Part B. Pevonedistat was administered after the paclitaxel and carboplatin chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
|
|---|---|---|
|
Part A: Volume of Distribution at Steady State After Intravenous Administration (Vss) for Pevonedistat Without Rifampin (Day 1) and With Rifampin (Day 10)
Pevonedistat with rifampin (Day 10)
|
296.10 liter
Standard Deviation 136.297
|
—
|
|
Part A: Volume of Distribution at Steady State After Intravenous Administration (Vss) for Pevonedistat Without Rifampin (Day 1) and With Rifampin (Day 10)
Pevonedistat without rifampin (Day 1)
|
312.82 liter
Standard Deviation 144.495
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 10 pre-dose and at multiple time points (up to 48 hours) post-dosePopulation: The PK-evaluable population was defined as all enrolled participants who a) received the protocol specified single pevonedistat dose in Part A; b) did not receive any excluded medications throughout the completion of Part A; and c) had sufficient concentration-time data to permit reliable estimation of PK parameters. As planned, this outcome measure was only assessed in Part A. Here number analyzed "n" signifies participants who were evaluable for this outcome measure at given time points.
Outcome measures
| Measure |
Part A: Pevonedistat 50 mg/m^2 + Rifampin 600 mg
n=20 Participants
Pevonedistat 50 mg/m\^2, infusion, intravenously, once on Days 1 and 10, and then rifampin 600 mg, capsule, orally, once daily from Day 3 up to Day 11 in Part A. Pevonedistat was not administered from Day 2 through Day 9.
|
Part B: Pevonedistat 20 mg/m^2 + Carboplatin AUC5 + Paclitaxel 175 mg/m^2
Pevonedistat 20 mg/m\^2, infusion, intravenously in combination with carboplatin AUC at the dose of 5 mg\*min/mL, infusion, intravenously and paclitaxel 175 mg/m\^2, infusion, intravenously, once on Day 1 of 21-day cycle, followed by pevonedistat 20 mg/m\^2, infusion, intravenously alone once on Days 3 and 5 in each 21-day cycle for up to 17 cycles or symptomatic deterioration or disease progression, treatment was discontinued for another reason, or until the study was stopped in Part B. Pevonedistat was administered after the paclitaxel and carboplatin chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
|
|---|---|---|
|
Part A: Terminal Disposition Phase Half-life (T1/2z) for Pevonedistat Without Rifampin (Day 1) and With Rifampin (Day 10)
Pevonedistat without rifampin (Day 1)
|
7.442 hour
Standard Deviation 1.3846
|
—
|
|
Part A: Terminal Disposition Phase Half-life (T1/2z) for Pevonedistat Without Rifampin (Day 1) and With Rifampin (Day 10)
Pevonedistat with rifampin (Day 10)
|
5.708 hour
Standard Deviation 1.3665
|
—
|
SECONDARY outcome
Timeframe: Up to Cycle 17 (end of treatment) (Cycle length =21 days)Population: The response-evaluable population was defined as all participants who received at least 1 dose of study drug in Part B, had measurable disease as entry criteria for Part B, and had at least 1 postbaseline disease assessment. As planned, this outcome measure was only assessed in Part B.
Best overall response was defined as participants with best response among complete response (CR) or partial response (PR) or stable disease (SD), or progressive disease (PD). It was assessed by investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target and non-target) must have reduction in short axis to less than (\<) 10 millimeter (mm). PR: at least 30 percent (%) decrease in sum of diameter of target lesions, taking as reference baseline sum of diameter. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference smallest sum of diameter. PD: at least 20% increase in sum of diameter of target lesions, taking as reference, smallest sum on study.
Outcome measures
| Measure |
Part A: Pevonedistat 50 mg/m^2 + Rifampin 600 mg
n=6 Participants
Pevonedistat 50 mg/m\^2, infusion, intravenously, once on Days 1 and 10, and then rifampin 600 mg, capsule, orally, once daily from Day 3 up to Day 11 in Part A. Pevonedistat was not administered from Day 2 through Day 9.
|
Part B: Pevonedistat 20 mg/m^2 + Carboplatin AUC5 + Paclitaxel 175 mg/m^2
n=7 Participants
Pevonedistat 20 mg/m\^2, infusion, intravenously in combination with carboplatin AUC at the dose of 5 mg\*min/mL, infusion, intravenously and paclitaxel 175 mg/m\^2, infusion, intravenously, once on Day 1 of 21-day cycle, followed by pevonedistat 20 mg/m\^2, infusion, intravenously alone once on Days 3 and 5 in each 21-day cycle for up to 17 cycles or symptomatic deterioration or disease progression, treatment was discontinued for another reason, or until the study was stopped in Part B. Pevonedistat was administered after the paclitaxel and carboplatin chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
|
|---|---|---|
|
Part B: Number of Participants With Best Overall Response as Per Investigator's Assessment
PR
|
2 Participants
|
1 Participants
|
|
Part B: Number of Participants With Best Overall Response as Per Investigator's Assessment
PD
|
2 Participants
|
3 Participants
|
|
Part B: Number of Participants With Best Overall Response as Per Investigator's Assessment
CR
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants With Best Overall Response as Per Investigator's Assessment
SD
|
2 Participants
|
3 Participants
|
Adverse Events
Part A: Pevonedistat 50 mg/m^2 + Rifampin 600 mg
Serious events: 3 serious events
Other events: 11 other events
Deaths: 1 deaths
Part B: Pevonedistat 25 mg/m^2 + Docetaxel 75 mg/m^2
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
Part B: Pevonedistat 20 mg/m^2 + Carboplatin AUC5+ Paclitaxel 175 mg/m^2
Serious events: 4 serious events
Other events: 8 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Part A: Pevonedistat 50 mg/m^2 + Rifampin 600 mg
n=20 participants at risk
Pevonedistat 50 mg/m\^2, infusion, intravenously, once on Days 1 and 10, and then rifampin 600 mg, capsule, orally, once daily from Day 3 up to Day 11 in Part A. Pevonedistat was not administered from Day 2 through Day 9.
|
Part B: Pevonedistat 25 mg/m^2 + Docetaxel 75 mg/m^2
n=9 participants at risk
Pevonedistat 25 mg/m\^2, infusion, intravenously in combination with docetaxel 75 mg/m\^2, infusion, intravenously on Day 1 of 21-day cycle, followed by pevonedistat 25 mg/m\^2, infusion, intravenously alone once on Days 3 and 5 in each 21-day cycle for up to 17 cycles or symptomatic deterioration or disease progression, treatment discontinuation for another reason, or until the study was stopped in Part B. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
|
Part B: Pevonedistat 20 mg/m^2 + Carboplatin AUC5+ Paclitaxel 175 mg/m^2
n=8 participants at risk
Pevonedistat 20 mg/m\^2, infusion, intravenously in combination with carboplatin AUC at the dose of 5 mg\*min/mL, infusion, intravenously and paclitaxel 175 mg/m\^2, infusion, intravenously, once on Day 1 of 21-day cycle, followed by pevonedistat 20 mg/m\^2, infusion, intravenously alone once on Days 3 and 5 in each 21-day cycle for up to 17 cycles or symptomatic deterioration or disease progression, treatment was discontinued for another reason, or until the study was stopped in Part B. Pevonedistat was administered after the paclitaxel and carboplatin chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
|
|---|---|---|---|
|
Immune system disorders
Hypersensitivity
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Pneumonia
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
22.2%
2/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Septic shock
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Acute kidney injury
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Enterocolitis infectious
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Sepsis
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Rectal haemorrhage
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Dyspnoea
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Hypoxia
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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 |
Part A: Pevonedistat 50 mg/m^2 + Rifampin 600 mg
n=20 participants at risk
Pevonedistat 50 mg/m\^2, infusion, intravenously, once on Days 1 and 10, and then rifampin 600 mg, capsule, orally, once daily from Day 3 up to Day 11 in Part A. Pevonedistat was not administered from Day 2 through Day 9.
|
Part B: Pevonedistat 25 mg/m^2 + Docetaxel 75 mg/m^2
n=9 participants at risk
Pevonedistat 25 mg/m\^2, infusion, intravenously in combination with docetaxel 75 mg/m\^2, infusion, intravenously on Day 1 of 21-day cycle, followed by pevonedistat 25 mg/m\^2, infusion, intravenously alone once on Days 3 and 5 in each 21-day cycle for up to 17 cycles or symptomatic deterioration or disease progression, treatment discontinuation for another reason, or until the study was stopped in Part B. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
|
Part B: Pevonedistat 20 mg/m^2 + Carboplatin AUC5+ Paclitaxel 175 mg/m^2
n=8 participants at risk
Pevonedistat 20 mg/m\^2, infusion, intravenously in combination with carboplatin AUC at the dose of 5 mg\*min/mL, infusion, intravenously and paclitaxel 175 mg/m\^2, infusion, intravenously, once on Day 1 of 21-day cycle, followed by pevonedistat 20 mg/m\^2, infusion, intravenously alone once on Days 3 and 5 in each 21-day cycle for up to 17 cycles or symptomatic deterioration or disease progression, treatment was discontinued for another reason, or until the study was stopped in Part B. Pevonedistat was administered after the paclitaxel and carboplatin chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
30.0%
6/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
3/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
25.0%
2/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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 upper
|
10.0%
2/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
|
10.0%
2/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
22.2%
2/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
25.0%
2/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
|
15.0%
3/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
55.6%
5/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
25.0%
2/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
|
10.0%
2/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
22.2%
2/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
|
10.0%
2/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
3/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
|
10.0%
2/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
|
10.0%
2/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
22.2%
2/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
|
20.0%
4/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
22.2%
2/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
|
10.0%
2/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Flank pain
|
10.0%
2/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
|
10.0%
2/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Headache
|
10.0%
2/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Dyspnoea exertional
|
10.0%
2/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
37.5%
3/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
|
Eye disorders
Dry eye
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
|
Eye disorders
Photopsia
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
|
Eye disorders
Visual impairment
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
37.5%
3/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
37.5%
3/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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 tenderness
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Colitis
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Dry mouth
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Dysphagia
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Proctalgia
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Asthenia
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
22.2%
2/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Localised oedema
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Medical device site oedema
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Peripheral swelling
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Urinary tract infection
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
44.4%
4/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Conjunctivitis
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Herpes zoster
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Pneumonia
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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 abrasion
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Vulvovaginal injury
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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 bilirubin increased
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
25.0%
2/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
25.0%
2/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Haematocrit decreased
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Liver function test increased
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Red blood cell count decreased
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Hypoalbuminaemia
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Hypophosphataemia
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
22.2%
2/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Fluid overload
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Hyperglycaemia
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Hypokalaemia
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Hypomagnesaemia
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Hyponatraemia
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Hypovolaemia
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Pain in extremity
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
37.5%
3/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Arthralgia
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Bone pain
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
22.2%
2/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Joint swelling
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Myalgia
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Peripheral sensory neuropathy
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
22.2%
2/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
4/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Peripheral motor neuropathy
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
22.2%
2/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Dysgeusia
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Paraesthesia
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Syncope
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Anxiety
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Haematuria
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
25.0%
2/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Sinus congestion
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Cough
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Dyspnoea
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Epistaxis
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Hiccups
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Pleural effusion
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Pneumothorax
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Productive cough
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Respiratory disorder
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Wheezing
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
22.2%
2/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
22.2%
2/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Nail disorder
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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
Hypotension
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
22.2%
2/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B])
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