Trial Outcomes & Findings for Dose Escalation and Dose Expansion Study of IPN60090 in Patients With Advanced Solid Tumours (NCT NCT03894540)
NCT ID: NCT03894540
Last Updated: 2022-09-13
Results Overview
An adverse event (AE) is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a study drug, whether or not considered causally related to the study drug. An undesirable medical condition can be symptoms, signs or the abnormal results of an investigation. An SAE is any AE that: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; results in congenital anomaly or birth defect; or is medically important. A TEAE is defined as any AE that began or worsened following the first administration of study drugs. AEs were recorded and graded according of the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0. * Grade 1 = mild, * Grade 2 = moderate, * Grade 3 = severe, * Grade 4 = life threatening/disabling, * Grade 5 = death (related to AE).
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
22 participants
Primary outcome timeframe
TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Results posted on
2022-09-13
Participant Flow
This Phase 1 first in human dose escalation and dose expansion study was conducted in participants with advanced solid tumours at 1 investigational site in United States of America between 22 March 2019 and 21 December 2020. The sponsor decided to terminate the study during the dose escalation phase (Part A) of the study following an internal portfolio review.
The study was divided into 4 parts: Part A (dose escalation and dose expansion of IPN60090 monotherapy); Part B (dose escalation and dose expansion of IPN60090 + pembrolizumab); Part C (dose escalation and dose expansion of IPN60090 + paclitaxel); and Part D (food effect on IPN60090). Parts B, C and D were not performed due to study termination. A total of 22 participants received IPN60090 in Part A of the study.
Participant milestones
| Measure |
IPN60090 20 mg
Participants received IPN60090 20 milligram (mg) capsules orally twice daily (BID) up to Cycle 7 in Part A of the study.
|
IPN60090 40 mg
Participants received IPN60090 40 mg capsules orally BID up to Cycle 2 in Part A of the study.
|
IPN60090 80 mg
Participants received IPN60090 80 mg capsules orally BID up to Cycle 5 in Part A of the study.
|
IPN60090 120 mg
Participants received IPN60090 120 mg capsules orally BID up to Cycle 9 in Part A of the study.
|
IPN60090 180 mg
Participants received IPN60090 180 mg capsules orally BID up to Cycle 9 in Part A of the study.
|
IPN60090 240 mg
Participants received IPN60090 240 mg capsules orally BID up to Cycle 4 in Part A of the study.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
1
|
4
|
11
|
4
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
4
|
11
|
4
|
Reasons for withdrawal
| Measure |
IPN60090 20 mg
Participants received IPN60090 20 milligram (mg) capsules orally twice daily (BID) up to Cycle 7 in Part A of the study.
|
IPN60090 40 mg
Participants received IPN60090 40 mg capsules orally BID up to Cycle 2 in Part A of the study.
|
IPN60090 80 mg
Participants received IPN60090 80 mg capsules orally BID up to Cycle 5 in Part A of the study.
|
IPN60090 120 mg
Participants received IPN60090 120 mg capsules orally BID up to Cycle 9 in Part A of the study.
|
IPN60090 180 mg
Participants received IPN60090 180 mg capsules orally BID up to Cycle 9 in Part A of the study.
|
IPN60090 240 mg
Participants received IPN60090 240 mg capsules orally BID up to Cycle 4 in Part A of the study.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Progressive Disease Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
|
0
|
0
|
1
|
3
|
2
|
3
|
|
Overall Study
Progressive Disease Clinical
|
1
|
1
|
0
|
1
|
5
|
1
|
|
Overall Study
Study termination by sponsor
|
0
|
0
|
0
|
0
|
2
|
0
|
Baseline Characteristics
Dose Escalation and Dose Expansion Study of IPN60090 in Patients With Advanced Solid Tumours
Baseline characteristics by cohort
| Measure |
IPN60090 20 mg
n=1 Participants
Participants received IPN60090 20 mg capsules orally BID up to Cycle 7 in Part A of the study.
|
IPN60090 40 mg
n=1 Participants
Participants received IPN60090 40 mg capsules orally BID up to Cycle 2 in Part A of the study.
|
IPN60090 80 mg
n=1 Participants
Participants received IPN60090 80 mg capsules orally BID up to Cycle 5 in Part A of the study.
|
IPN60090 120 mg
n=4 Participants
Participants received IPN60090 120 mg capsules orally BID up to Cycle 9 in Part A of the study.
|
IPN60090 180 mg
n=11 Participants
Participants received IPN60090 180 mg capsules orally BID up to Cycle 9 in Part A of the study.
|
IPN60090 240 mg
n=4 Participants
Participants received IPN60090 240 mg capsules orally BID up to Cycle 4 in Part A of the study.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
70.0 years
STANDARD_DEVIATION NA • n=93 Participants
|
47.0 years
STANDARD_DEVIATION NA • n=4 Participants
|
63.0 years
STANDARD_DEVIATION NA • n=27 Participants
|
57.0 years
STANDARD_DEVIATION 15.43 • n=483 Participants
|
67.6 years
STANDARD_DEVIATION 7.15 • n=36 Participants
|
47.8 years
STANDARD_DEVIATION 18.82 • n=10 Participants
|
61.0 years
STANDARD_DEVIATION 13.49 • n=115 Participants
|
|
Age, Customized
16 to 64 years
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
3 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
|
Age, Customized
65 to 84 years
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
16 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
9 Participants
n=36 Participants
|
3 Participants
n=10 Participants
|
16 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
9 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
18 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).Population: Safety population included all participants who were exposed to (or started receiving) IPN60090.
An adverse event (AE) is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a study drug, whether or not considered causally related to the study drug. An undesirable medical condition can be symptoms, signs or the abnormal results of an investigation. An SAE is any AE that: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; results in congenital anomaly or birth defect; or is medically important. A TEAE is defined as any AE that began or worsened following the first administration of study drugs. AEs were recorded and graded according of the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0. * Grade 1 = mild, * Grade 2 = moderate, * Grade 3 = severe, * Grade 4 = life threatening/disabling, * Grade 5 = death (related to AE).
Outcome measures
| Measure |
IPN60090 20 mg
n=1 Participants
Participants received IPN60090 20 mg capsules orally BID up to Cycle 7 in Part A of the study.
|
IPN60090 40 mg
n=1 Participants
Participants received IPN60090 40 mg capsules orally BID up to Cycle 2 in Part A of the study.
|
IPN60090 80 mg
n=1 Participants
Participants received IPN60090 80 mg capsules orally BID up to Cycle 5 in Part A of the study.
|
IPN60090 120 mg
n=4 Participants
Participants received IPN60090 120 mg capsules orally BID up to Cycle 9 in Part A of the study.
|
IPN60090 180 mg
n=11 Participants
Participants received IPN60090 180 mg capsules orally BID up to Cycle 9 in Part A of the study.
|
IPN60090 240 mg
n=4 Participants
Participants received IPN60090 240 mg capsules orally BID up to Cycle 4 in Part A of the study.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs) in Part A
Any TEAEs
|
1 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
11 Participants
|
4 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs) in Part A
TEAEs with NCI-CTCAE 5.0 Grade 3/4/5
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
8 Participants
|
3 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs) in Part A
Treatment emergent SAEs
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs) in Part A
TEAEs leading to study treatment discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs) in Part A
TEAEs leading to interruption or decrease of study treatment
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
6 Participants
|
1 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs) in Part A
TEAEs leading to interruption of study treatment
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
6 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to Cycle 1 Day 21 of Part APopulation: DLT evaluable population included all participants from the safety population who were evaluable for DLT (participants who completed at least one cycle of treatment and received ≥75% of the total planned dose of IPN60090 over the DLT assessment period).
The maximum tolerated dose (MTD) is defined as the maximum dose of IPN60090 administered BID for 21 days, so that no more than 30% of participants experience a DLT. The MTD was determined using a Bayesian Optimal Interval design. The DLT assessment period was the first 21 days of treatment (one cycle).
Outcome measures
| Measure |
IPN60090 20 mg
n=1 Participants
Participants received IPN60090 20 mg capsules orally BID up to Cycle 7 in Part A of the study.
|
IPN60090 40 mg
n=1 Participants
Participants received IPN60090 40 mg capsules orally BID up to Cycle 2 in Part A of the study.
|
IPN60090 80 mg
n=1 Participants
Participants received IPN60090 80 mg capsules orally BID up to Cycle 5 in Part A of the study.
|
IPN60090 120 mg
n=4 Participants
Participants received IPN60090 120 mg capsules orally BID up to Cycle 9 in Part A of the study.
|
IPN60090 180 mg
n=11 Participants
Participants received IPN60090 180 mg capsules orally BID up to Cycle 9 in Part A of the study.
|
IPN60090 240 mg
n=4 Participants
Participants received IPN60090 240 mg capsules orally BID up to Cycle 4 in Part A of the study.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Dose-Limiting Toxicities (DLT) in Cycle 1 of Part A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Cycle 1 Day 21 of Part APopulation: DLT evaluable population included all participants from the safety population who were evaluable for DLT (participants who completed at least one cycle of treatment and received ≥75% of the total planned dose of IPN60090 over the DLT assessment period).
The recommended dose was determined by the safety review committee following an ad-hoc review of the safety and tolerability data during Part A of the study.
Outcome measures
| Measure |
IPN60090 20 mg
n=22 Participants
Participants received IPN60090 20 mg capsules orally BID up to Cycle 7 in Part A of the study.
|
IPN60090 40 mg
Participants received IPN60090 40 mg capsules orally BID up to Cycle 2 in Part A of the study.
|
IPN60090 80 mg
Participants received IPN60090 80 mg capsules orally BID up to Cycle 5 in Part A of the study.
|
IPN60090 120 mg
Participants received IPN60090 120 mg capsules orally BID up to Cycle 9 in Part A of the study.
|
IPN60090 180 mg
Participants received IPN60090 180 mg capsules orally BID up to Cycle 9 in Part A of the study.
|
IPN60090 240 mg
Participants received IPN60090 240 mg capsules orally BID up to Cycle 4 in Part A of the study.
|
|---|---|---|---|---|---|---|
|
Recommended Dose of IPN60090 in Part A
|
180 mg
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: RECIST assessments performed at baseline (within 28 days before start of study drug), every 6 weeks +/-1 week for first 24 weeks, then every 12 weeks +/-2 weeks thereafter. Up to data cut-off for study termination (maximum of 247 days).Population: Efficacy population included all participants who received at least one dose of IPN60090.
The BOR is defined as the best response designation \[in the order of complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD)\] for each participant that is recorded between the date of the first dose of the study drug and the date of documented disease progression per RECIST 1.1 or the date of subsequent anticancer therapy whichever occurs first. Per RECIST v1.1, CR is disappearance of all target lesions; PR is \>=30% decrease in the sum of the longest diameter of target lesions; and overall response = CR + PR.
Outcome measures
| Measure |
IPN60090 20 mg
n=1 Participants
Participants received IPN60090 20 mg capsules orally BID up to Cycle 7 in Part A of the study.
|
IPN60090 40 mg
n=1 Participants
Participants received IPN60090 40 mg capsules orally BID up to Cycle 2 in Part A of the study.
|
IPN60090 80 mg
n=1 Participants
Participants received IPN60090 80 mg capsules orally BID up to Cycle 5 in Part A of the study.
|
IPN60090 120 mg
n=4 Participants
Participants received IPN60090 120 mg capsules orally BID up to Cycle 9 in Part A of the study.
|
IPN60090 180 mg
n=11 Participants
Participants received IPN60090 180 mg capsules orally BID up to Cycle 9 in Part A of the study.
|
IPN60090 240 mg
n=4 Participants
Participants received IPN60090 240 mg capsules orally BID up to Cycle 4 in Part A of the study.
|
|---|---|---|---|---|---|---|
|
Best Overall Response (BOR) in Part A
CR
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Best Overall Response (BOR) in Part A
PR
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Best Overall Response (BOR) in Part A
SD
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
9 Participants
|
2 Participants
|
|
Best Overall Response (BOR) in Part A
PD
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Best Overall Response (BOR) in Part A
Not evaluable
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: RECIST assessments performed at baseline (within 28 days before start of study drug), every 6 weeks +/-1 week for first 24 weeks, then every 12 weeks +/-2 weeks thereafter. Up to data cut-off for study termination (maximum of 247 days).Population: Efficacy population included all participants who received at least one dose of IPN60090.
The ORR is defined as the percentage of participants in whom the BOR is equal to CR and PR for Part A. The BOR is defined as the best response designation (in the order of CR, PR, SD, PD) for each participant that is recorded between the date of the first dose of the study drug and the date of documented disease progression per RECIST 1.1 or the date of subsequent anticancer therapy whichever occurs first. Per RECIST v1.1, CR is disappearance of all target lesions; PR is \>=30% decrease in the sum of the longest diameter of target lesions; and overall response = CR + PR.
Outcome measures
| Measure |
IPN60090 20 mg
n=1 Participants
Participants received IPN60090 20 mg capsules orally BID up to Cycle 7 in Part A of the study.
|
IPN60090 40 mg
n=1 Participants
Participants received IPN60090 40 mg capsules orally BID up to Cycle 2 in Part A of the study.
|
IPN60090 80 mg
n=1 Participants
Participants received IPN60090 80 mg capsules orally BID up to Cycle 5 in Part A of the study.
|
IPN60090 120 mg
n=4 Participants
Participants received IPN60090 120 mg capsules orally BID up to Cycle 9 in Part A of the study.
|
IPN60090 180 mg
n=11 Participants
Participants received IPN60090 180 mg capsules orally BID up to Cycle 9 in Part A of the study.
|
IPN60090 240 mg
n=4 Participants
Participants received IPN60090 240 mg capsules orally BID up to Cycle 4 in Part A of the study.
|
|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR) in Part A
|
0 percentage of participants
Interval 0.0 to 97.5
|
0 percentage of participants
Interval 0.0 to 97.5
|
0 percentage of participants
Interval 0.0 to 97.5
|
0 percentage of participants
Interval 0.0 to 60.2
|
0 percentage of participants
Interval 0.0 to 28.5
|
0 percentage of participants
Interval 0.0 to 60.2
|
SECONDARY outcome
Timeframe: RECIST assessments performed at baseline (within 28 days before start of study drug), every 6 weeks +/-1 week for first 24 weeks, then every 12 weeks +/-2 weeks thereafter. Up to data cut-off for study termination (maximum of 247 days).Population: Efficacy population included all participants who received at least one dose of IPN60090.
The DCR is defined as the percentage of participants in whom the BOR is equal to CR, PR or SD for Part A. The BOR is defined as the best response designation (in the order of CR, PR, SD, PD) for each participant that is recorded between the date of the first dose of the study drug and the date of documented disease progression per RECIST 1.1 or the date of subsequent anticancer therapy whichever occurs first. Per RECIST v1.1, CR is disappearance of all target lesions; PR is \>=30% decrease in the sum of the longest diameter of target lesions; and overall response = CR + PR.
Outcome measures
| Measure |
IPN60090 20 mg
n=1 Participants
Participants received IPN60090 20 mg capsules orally BID up to Cycle 7 in Part A of the study.
|
IPN60090 40 mg
n=1 Participants
Participants received IPN60090 40 mg capsules orally BID up to Cycle 2 in Part A of the study.
|
IPN60090 80 mg
n=1 Participants
Participants received IPN60090 80 mg capsules orally BID up to Cycle 5 in Part A of the study.
|
IPN60090 120 mg
n=4 Participants
Participants received IPN60090 120 mg capsules orally BID up to Cycle 9 in Part A of the study.
|
IPN60090 180 mg
n=11 Participants
Participants received IPN60090 180 mg capsules orally BID up to Cycle 9 in Part A of the study.
|
IPN60090 240 mg
n=4 Participants
Participants received IPN60090 240 mg capsules orally BID up to Cycle 4 in Part A of the study.
|
|---|---|---|---|---|---|---|
|
Disease Control Rate (DCR) in Part A
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
75.0 percentage of participants
Interval 19.4 to 99.4
|
81.8 percentage of participants
Interval 48.2 to 97.7
|
50.0 percentage of participants
Interval 6.8 to 93.2
|
SECONDARY outcome
Timeframe: RECIST assessments performed at baseline (within 28 days before start of study drug), every 6 weeks +/-1 week for first 24 weeks, then every 12 weeks +/-2 weeks thereafter. Up to data cut-off for study termination (maximum of 247 days).Population: Efficacy population included all participants who received at least one dose of IPN60090.
The PFS is defined as the time from first dose of study drug to the first documented objective disease progression (for RECIST 1.1), clinical disease progression collected at end of treatment, or death due to any cause, whichever occurred first. Per RECIST 1.1, progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
IPN60090 20 mg
n=1 Participants
Participants received IPN60090 20 mg capsules orally BID up to Cycle 7 in Part A of the study.
|
IPN60090 40 mg
n=1 Participants
Participants received IPN60090 40 mg capsules orally BID up to Cycle 2 in Part A of the study.
|
IPN60090 80 mg
n=1 Participants
Participants received IPN60090 80 mg capsules orally BID up to Cycle 5 in Part A of the study.
|
IPN60090 120 mg
n=4 Participants
Participants received IPN60090 120 mg capsules orally BID up to Cycle 9 in Part A of the study.
|
IPN60090 180 mg
n=11 Participants
Participants received IPN60090 180 mg capsules orally BID up to Cycle 9 in Part A of the study.
|
IPN60090 240 mg
n=4 Participants
Participants received IPN60090 240 mg capsules orally BID up to Cycle 4 in Part A of the study.
|
|---|---|---|---|---|---|---|
|
Mean Progression Free Survival (PFS) in Part A
|
4.90 months
Standard Deviation NA
Standard deviation cannot be calculated when only one participant analyzed.
|
1.45 months
Standard Deviation NA
Standard deviation cannot be calculated when only one participant analyzed.
|
2.73 months
Standard Deviation NA
Standard deviation cannot be calculated when only one participant analyzed.
|
2.81 months
Standard Deviation 2.193
|
4.37 months
Standard Deviation 2.766
|
1.52 months
Standard Deviation 0.073
|
SECONDARY outcome
Timeframe: RECIST assessments performed at baseline (within 28 days before start of study drug), every 6 weeks +/-1 week for first 24 weeks, then every 12 weeks +/-2 weeks thereafter. Up to data cut-off for study termination (maximum of 247 days).Population: Efficacy population included all participants who received at least one dose of IPN60090.
The OS is defined as the time from first dose of study drug to death due to any cause. Participants who were lost to follow-up or who were still alive at the time of analysis is censored at the last day the participant was known to be alive or data cut-off date, whichever occurred first.
Outcome measures
| Measure |
IPN60090 20 mg
n=1 Participants
Participants received IPN60090 20 mg capsules orally BID up to Cycle 7 in Part A of the study.
|
IPN60090 40 mg
n=1 Participants
Participants received IPN60090 40 mg capsules orally BID up to Cycle 2 in Part A of the study.
|
IPN60090 80 mg
n=1 Participants
Participants received IPN60090 80 mg capsules orally BID up to Cycle 5 in Part A of the study.
|
IPN60090 120 mg
n=4 Participants
Participants received IPN60090 120 mg capsules orally BID up to Cycle 9 in Part A of the study.
|
IPN60090 180 mg
n=11 Participants
Participants received IPN60090 180 mg capsules orally BID up to Cycle 9 in Part A of the study.
|
IPN60090 240 mg
n=4 Participants
Participants received IPN60090 240 mg capsules orally BID up to Cycle 4 in Part A of the study.
|
|---|---|---|---|---|---|---|
|
Mean Overall Survival (OS) in Part A
|
5.03 months
Standard Deviation NA
Standard deviation cannot be calculated when only one participant analyzed.
|
6.21 months
Standard Deviation NA
Standard deviation cannot be calculated when only one participant analyzed.
|
13.24 months
Standard Deviation NA
Standard deviation cannot be calculated when only one participant analyzed.
|
6.35 months
Standard Deviation 4.433
|
11.00 months
Standard Deviation 5.421
|
11.01 months
Standard Deviation 4.409
|
SECONDARY outcome
Timeframe: Baseline (within 28 days before start of study drug) and post-baseline, up to data cut-off for study termination (maximum of 247 days).Population: Efficacy population included all participants who received at least one dose of IPN60090. Only participants with valid baseline and at least one post-baseline value of the sum of diameters are included.
All measurable lesions up to a maximum of two lesions per organ and five lesions in total, representative of all involved organs, identified as target lesions and measured at baseline. Baseline is defined as the last measurement prior to the first dose of study drug.
Outcome measures
| Measure |
IPN60090 20 mg
n=1 Participants
Participants received IPN60090 20 mg capsules orally BID up to Cycle 7 in Part A of the study.
|
IPN60090 40 mg
n=1 Participants
Participants received IPN60090 40 mg capsules orally BID up to Cycle 2 in Part A of the study.
|
IPN60090 80 mg
n=1 Participants
Participants received IPN60090 80 mg capsules orally BID up to Cycle 5 in Part A of the study.
|
IPN60090 120 mg
n=2 Participants
Participants received IPN60090 120 mg capsules orally BID up to Cycle 9 in Part A of the study.
|
IPN60090 180 mg
n=9 Participants
Participants received IPN60090 180 mg capsules orally BID up to Cycle 9 in Part A of the study.
|
IPN60090 240 mg
n=4 Participants
Participants received IPN60090 240 mg capsules orally BID up to Cycle 4 in Part A of the study.
|
|---|---|---|---|---|---|---|
|
Mean Best Percent Change From Baseline in the Sum of Diameters of the Target Lesions at Minimum Post-Baseline in Part A
|
0.0 percent change
Standard Deviation NA
Standard deviation cannot be calculated when only one participant analyzed.
|
7.7 percent change
Standard Deviation NA
Standard deviation cannot be calculated when only one participant analyzed.
|
-21.6 percent change
Standard Deviation NA
Standard deviation cannot be calculated when only one participant analyzed.
|
-10.2 percent change
Standard Deviation 14.48
|
3.6 percent change
Standard Deviation 18.05
|
18.3 percent change
Standard Deviation 20.88
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5, 1, 2, 4, 8 and 12 hours post-dose on Cycle 1 Day 1 and Cycle 1 Day 14 in Part APopulation: The PK population for noncompartmental analysis included all participants who had no major protocol deviation affecting the PK variables and who had a sufficient number of IPN60090 plasma concentrations to estimate the main PK parameters. Summarized PK results are presented for IPN60090 120 mg, IPN60090 180 mg and IPN60090 240 mg reporting groups only.
Blood samples were collected to determine Cmax of IPN60090. The pharmacokinetics (PK) of IPN60090 plasma concentrations were performed using noncompartmental analysis.
Outcome measures
| Measure |
IPN60090 20 mg
n=4 Participants
Participants received IPN60090 20 mg capsules orally BID up to Cycle 7 in Part A of the study.
|
IPN60090 40 mg
n=11 Participants
Participants received IPN60090 40 mg capsules orally BID up to Cycle 2 in Part A of the study.
|
IPN60090 80 mg
n=4 Participants
Participants received IPN60090 80 mg capsules orally BID up to Cycle 5 in Part A of the study.
|
IPN60090 120 mg
Participants received IPN60090 120 mg capsules orally BID up to Cycle 9 in Part A of the study.
|
IPN60090 180 mg
Participants received IPN60090 180 mg capsules orally BID up to Cycle 9 in Part A of the study.
|
IPN60090 240 mg
Participants received IPN60090 240 mg capsules orally BID up to Cycle 4 in Part A of the study.
|
|---|---|---|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of IPN60090 in Part A
Cycle 1 Day 1
|
10019 nanogram per milliliter (ng/mL)
Standard Deviation 4429
|
13467 nanogram per milliliter (ng/mL)
Standard Deviation 8780
|
13068 nanogram per milliliter (ng/mL)
Standard Deviation 11503
|
—
|
—
|
—
|
|
Maximum Observed Concentration (Cmax) of IPN60090 in Part A
Cycle 1 Day 14
|
19595 nanogram per milliliter (ng/mL)
Standard Deviation 16103
|
24395 nanogram per milliliter (ng/mL)
Standard Deviation 9912
|
25793 nanogram per milliliter (ng/mL)
Standard Deviation 16215
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5, 1, 2, 4, 8 and 12 hours post-dose on Cycle 1 Day 1 and Cycle 1 Day 14 in Part APopulation: The PK population for noncompartmental analysis included all participants who had no major protocol deviation affecting the PK variables and who had a sufficient number of IPN60090 plasma concentrations to estimate the main PK parameters. Summarized PK results are presented for IPN60090 120 mg, IPN60090 180 mg and IPN60090 240 mg reporting groups only.
Blood samples were collected to determine Tmax of IPN60090. The PK of IPN60090 plasma concentrations were performed using noncompartmental analysis.
Outcome measures
| Measure |
IPN60090 20 mg
n=4 Participants
Participants received IPN60090 20 mg capsules orally BID up to Cycle 7 in Part A of the study.
|
IPN60090 40 mg
n=11 Participants
Participants received IPN60090 40 mg capsules orally BID up to Cycle 2 in Part A of the study.
|
IPN60090 80 mg
n=4 Participants
Participants received IPN60090 80 mg capsules orally BID up to Cycle 5 in Part A of the study.
|
IPN60090 120 mg
Participants received IPN60090 120 mg capsules orally BID up to Cycle 9 in Part A of the study.
|
IPN60090 180 mg
Participants received IPN60090 180 mg capsules orally BID up to Cycle 9 in Part A of the study.
|
IPN60090 240 mg
Participants received IPN60090 240 mg capsules orally BID up to Cycle 4 in Part A of the study.
|
|---|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Concentration (Tmax) of IPN60090 in Part A
Cycle 1 Day 1
|
2.10 hours
Interval 1.0 to 4.08
|
4.00 hours
Interval 1.0 to 4.17
|
4.04 hours
Interval 1.08 to 4.13
|
—
|
—
|
—
|
|
Time to Reach Maximum Observed Concentration (Tmax) of IPN60090 in Part A
Cycle 1 Day 14
|
1.00 hours
Interval 0.93 to 2.0
|
2.00 hours
Interval 1.0 to 4.08
|
1.58 hours
Interval 0.0 to 4.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5, 1, 2, 4, 8 and 12 hours post-dose on Cycle 1 Day 14 in Part APopulation: The PK population for noncompartmental analysis included all participants who had no major protocol deviation affecting the PK variables and who had a sufficient number of IPN60090 plasma concentrations to estimate the main PK parameters. Summarized PK results are presented for IPN60090 120 mg, IPN60090 180 mg and IPN60090 240 mg reporting groups only.
Blood samples were collected to determine Ctrough of IPN60090. The PK of IPN60090 plasma concentrations were performed using noncompartmental analysis.
Outcome measures
| Measure |
IPN60090 20 mg
n=3 Participants
Participants received IPN60090 20 mg capsules orally BID up to Cycle 7 in Part A of the study.
|
IPN60090 40 mg
n=9 Participants
Participants received IPN60090 40 mg capsules orally BID up to Cycle 2 in Part A of the study.
|
IPN60090 80 mg
n=4 Participants
Participants received IPN60090 80 mg capsules orally BID up to Cycle 5 in Part A of the study.
|
IPN60090 120 mg
Participants received IPN60090 120 mg capsules orally BID up to Cycle 9 in Part A of the study.
|
IPN60090 180 mg
Participants received IPN60090 180 mg capsules orally BID up to Cycle 9 in Part A of the study.
|
IPN60090 240 mg
Participants received IPN60090 240 mg capsules orally BID up to Cycle 4 in Part A of the study.
|
|---|---|---|---|---|---|---|
|
Trough Plasma Concentration (Ctrough) of IPN60090 in Part A
|
9211 ng/mL
Standard Deviation 8149
|
14616 ng/mL
Standard Deviation 6654
|
20214 ng/mL
Standard Deviation 15970
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5, 1, 2, 4, 8 and 12 hours post-dose on Cycle 1 Day 1 and Cycle 1 Day 14 in Part APopulation: The PK population for noncompartmental analysis included all participants who had no major protocol deviation affecting the PK variables and who had a sufficient number of IPN60090 plasma concentrations to estimate the main PK parameters. Summarized PK results are presented for IPN60090 120 mg, IPN60090 180 mg and IPN60090 240 mg reporting groups only.
Blood samples were collected to determine AUC0-last of IPN60090. The PK of IPN60090 plasma concentrations were performed using noncompartmental analysis.
Outcome measures
| Measure |
IPN60090 20 mg
n=4 Participants
Participants received IPN60090 20 mg capsules orally BID up to Cycle 7 in Part A of the study.
|
IPN60090 40 mg
n=11 Participants
Participants received IPN60090 40 mg capsules orally BID up to Cycle 2 in Part A of the study.
|
IPN60090 80 mg
n=4 Participants
Participants received IPN60090 80 mg capsules orally BID up to Cycle 5 in Part A of the study.
|
IPN60090 120 mg
Participants received IPN60090 120 mg capsules orally BID up to Cycle 9 in Part A of the study.
|
IPN60090 180 mg
Participants received IPN60090 180 mg capsules orally BID up to Cycle 9 in Part A of the study.
|
IPN60090 240 mg
Participants received IPN60090 240 mg capsules orally BID up to Cycle 4 in Part A of the study.
|
|---|---|---|---|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of IPN60090 in Part A
Cycle 1 Day 1
|
62776 hour*ng/mL
Standard Deviation 31857
|
87061 hour*ng/mL
Standard Deviation 54015
|
67192 hour*ng/mL
Standard Deviation 54492
|
—
|
—
|
—
|
|
Area Under the Concentration Versus Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of IPN60090 in Part A
Cycle 1 Day 14
|
128699 hour*ng/mL
Standard Deviation 99755
|
188838 hour*ng/mL
Standard Deviation 91394
|
200845 hour*ng/mL
Standard Deviation 128710
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5, 1, 2, 4, 8 and 12 hours post-dose on Cycle 1 Day 1 in Part APopulation: The PK population for noncompartmental analysis included all participants who had no major protocol deviation affecting the PK variables and who had a sufficient number of IPN60090 plasma concentrations to estimate the main PK parameters. Summarized PK results are presented for IPN60090 120 mg, IPN60090 180 mg and IPN60090 240 mg reporting groups only.
Blood samples were collected to determine T1/2 of IPN60090. The PK of IPN60090 plasma concentrations were performed using noncompartmental analysis.
Outcome measures
| Measure |
IPN60090 20 mg
n=3 Participants
Participants received IPN60090 20 mg capsules orally BID up to Cycle 7 in Part A of the study.
|
IPN60090 40 mg
n=4 Participants
Participants received IPN60090 40 mg capsules orally BID up to Cycle 2 in Part A of the study.
|
IPN60090 80 mg
n=1 Participants
Participants received IPN60090 80 mg capsules orally BID up to Cycle 5 in Part A of the study.
|
IPN60090 120 mg
Participants received IPN60090 120 mg capsules orally BID up to Cycle 9 in Part A of the study.
|
IPN60090 180 mg
Participants received IPN60090 180 mg capsules orally BID up to Cycle 9 in Part A of the study.
|
IPN60090 240 mg
Participants received IPN60090 240 mg capsules orally BID up to Cycle 4 in Part A of the study.
|
|---|---|---|---|---|---|---|
|
Apparent Elimination Half-Life (T1/2) of IPN60090 in Part A
|
12.72 hours
Interval 9.01 to 25.48
|
6.92 hours
Interval 5.85 to 10.87
|
6.18 hours
Interval 6.18 to 6.18
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5, 1, 2, 4, 8 and 12 hours post-dose on Cycle 1 Day 1 in Part APopulation: The PK population for noncompartmental analysis included all participants who had no major protocol deviation affecting the PK variables and who had a sufficient number of IPN60090 plasma concentrations to estimate the main PK parameters. Summarized PK results are presented for IPN60090 120 mg, IPN60090 180 mg and IPN60090 240 mg reporting groups only.
Blood samples were collected to determine CL/F of IPN60090. The PK of IPN60090 plasma concentrations were performed using noncompartmental analysis.
Outcome measures
| Measure |
IPN60090 20 mg
n=3 Participants
Participants received IPN60090 20 mg capsules orally BID up to Cycle 7 in Part A of the study.
|
IPN60090 40 mg
n=4 Participants
Participants received IPN60090 40 mg capsules orally BID up to Cycle 2 in Part A of the study.
|
IPN60090 80 mg
n=1 Participants
Participants received IPN60090 80 mg capsules orally BID up to Cycle 5 in Part A of the study.
|
IPN60090 120 mg
Participants received IPN60090 120 mg capsules orally BID up to Cycle 9 in Part A of the study.
|
IPN60090 180 mg
Participants received IPN60090 180 mg capsules orally BID up to Cycle 9 in Part A of the study.
|
IPN60090 240 mg
Participants received IPN60090 240 mg capsules orally BID up to Cycle 4 in Part A of the study.
|
|---|---|---|---|---|---|---|
|
Apparent Total Body Clearance (CL/F) of IPN60090 in Part A
|
0.811 liter per hour
Standard Deviation 0.190
|
1.03 liter per hour
Standard Deviation 0.270
|
3.71 liter per hour
Standard Deviation NA
Standard deviation cannot be calculated when only one participant analyzed.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5, 1, 2, 4, 8 and 12 hours post-dose on Cycle 1 Day 1 in Part APopulation: The PK population for noncompartmental analysis included all participants who had no major protocol deviation affecting the PK variables and who had a sufficient number of IPN60090 plasma concentrations to estimate the main PK parameters. Summarized PK results are presented for IPN60090 120 mg, IPN60090 180 mg and IPN60090 240 mg reporting groups only.
Blood samples were collected to determine Vz/F of IPN60090. The PK of IPN60090 plasma concentrations were performed using noncompartmental analysis.
Outcome measures
| Measure |
IPN60090 20 mg
n=3 Participants
Participants received IPN60090 20 mg capsules orally BID up to Cycle 7 in Part A of the study.
|
IPN60090 40 mg
n=4 Participants
Participants received IPN60090 40 mg capsules orally BID up to Cycle 2 in Part A of the study.
|
IPN60090 80 mg
n=1 Participants
Participants received IPN60090 80 mg capsules orally BID up to Cycle 5 in Part A of the study.
|
IPN60090 120 mg
Participants received IPN60090 120 mg capsules orally BID up to Cycle 9 in Part A of the study.
|
IPN60090 180 mg
Participants received IPN60090 180 mg capsules orally BID up to Cycle 9 in Part A of the study.
|
IPN60090 240 mg
Participants received IPN60090 240 mg capsules orally BID up to Cycle 4 in Part A of the study.
|
|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution (Vz/F) of IPN60090 in Part A
|
20.0 liter
Standard Deviation 15.5
|
11.2 liter
Standard Deviation 3.35
|
33.0 liter
Standard Deviation NA
Standard deviation cannot be calculated when only one participant analyzed.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At 2 and 12 hours postdose on Cycle 1 Day 1; predose, 2 and 12 hours postdose on Cycle 1 Day 14; and predose, 2 and 2-4 hours postdose on Cycle 1 Day 15 in Part APopulation: Efficacy population included all participants who received at least one dose of IPN60090.
The target engagement is glutamate:glutamine (Glu:Gln) ratio in peripheral blood mononuclear cells. Glu:Gln ratio inhibition is calculated as (1 - post-baseline Glu:Gln ratio/Cycle 1 Day 1 predose Glu:Gln ratio) x 100%.
Outcome measures
| Measure |
IPN60090 20 mg
n=1 Participants
Participants received IPN60090 20 mg capsules orally BID up to Cycle 7 in Part A of the study.
|
IPN60090 40 mg
n=1 Participants
Participants received IPN60090 40 mg capsules orally BID up to Cycle 2 in Part A of the study.
|
IPN60090 80 mg
n=1 Participants
Participants received IPN60090 80 mg capsules orally BID up to Cycle 5 in Part A of the study.
|
IPN60090 120 mg
n=4 Participants
Participants received IPN60090 120 mg capsules orally BID up to Cycle 9 in Part A of the study.
|
IPN60090 180 mg
n=11 Participants
Participants received IPN60090 180 mg capsules orally BID up to Cycle 9 in Part A of the study.
|
IPN60090 240 mg
n=4 Participants
Participants received IPN60090 240 mg capsules orally BID up to Cycle 4 in Part A of the study.
|
|---|---|---|---|---|---|---|
|
Target Engagement in Part A
Cycle 1 Day 1: 2 hours postdose
|
—
|
75.66 ratio
Standard Deviation NA
Standard deviation cannot be calculated when only one participant analyzed.
|
67.06 ratio
Standard Deviation NA
Standard deviation cannot be calculated when only one participant analyzed.
|
85.02 ratio
Standard Deviation 8.734
|
86.13 ratio
Standard Deviation 7.216
|
82.65 ratio
Standard Deviation 14.286
|
|
Target Engagement in Part A
Cycle 1 Day 1: 12 hours postdose
|
—
|
61.90 ratio
Standard Deviation NA
Standard deviation cannot be calculated when only one participant analyzed.
|
34.12 ratio
Standard Deviation NA
Standard deviation cannot be calculated when only one participant analyzed.
|
72.47 ratio
Standard Deviation 19.188
|
75.43 ratio
Standard Deviation 17.521
|
70.94 ratio
Standard Deviation 18.055
|
|
Target Engagement in Part A
Cycle 1 Day 14: predose
|
50.45 ratio
Standard Deviation NA
Standard deviation cannot be calculated when only one participant analyzed.
|
36.51 ratio
Standard Deviation NA
Standard deviation cannot be calculated when only one participant analyzed.
|
80.42 ratio
Standard Deviation NA
Standard deviation cannot be calculated when only one participant analyzed.
|
82.59 ratio
Standard Deviation 12.622
|
83.15 ratio
Standard Deviation 11.554
|
83.12 ratio
Standard Deviation 10.962
|
|
Target Engagement in Part A
Cycle 1 Day 14: 2 hours postdose
|
65.77 ratio
Standard Deviation NA
Standard deviation cannot be calculated when only one participant analyzed.
|
75.66 ratio
Standard Deviation NA
Standard deviation cannot be calculated when only one participant analyzed.
|
84.42 ratio
Standard Deviation NA
Standard deviation cannot be calculated when only one participant analyzed.
|
88.30 ratio
Standard Deviation 7.798
|
91.83 ratio
Standard Deviation 3.099
|
87.48 ratio
Standard Deviation 6.257
|
|
Target Engagement in Part A
Cycle 1 Day 14: 12 hours postdose
|
50.45 ratio
Standard Deviation NA
Standard deviation cannot be calculated when only one participant analyzed.
|
69.31 ratio
Standard Deviation NA
Standard deviation cannot be calculated when only one participant analyzed.
|
84.87 ratio
Standard Deviation NA
Standard deviation cannot be calculated when only one participant analyzed.
|
82.00 ratio
Standard Deviation 13.609
|
86.51 ratio
Standard Deviation 5.474
|
74.38 ratio
Standard Deviation 22.991
|
|
Target Engagement in Part A
Cycle 1 Day 15: predose
|
72.07 ratio
Standard Deviation NA
Standard deviation cannot be calculated when only one participant analyzed.
|
56.61 ratio
Standard Deviation NA
Standard deviation cannot be calculated when only one participant analyzed.
|
72.40 ratio
Standard Deviation NA
Standard deviation cannot be calculated when only one participant analyzed.
|
87.25 ratio
Standard Deviation 4.898
|
86.67 ratio
Standard Deviation 3.767
|
86.67 ratio
Standard Deviation 9.394
|
|
Target Engagement in Part A
Cycle 1 Day 15: 2 hours postdose
|
79.28 ratio
Standard Deviation NA
Standard deviation cannot be calculated when only one participant analyzed.
|
71.43 ratio
Standard Deviation NA
Standard deviation cannot be calculated when only one participant analyzed.
|
79.97 ratio
Standard Deviation NA
Standard deviation cannot be calculated when only one participant analyzed.
|
—
|
89.57 ratio
Standard Deviation 3.125
|
—
|
|
Target Engagement in Part A
Cycle 1 Day 15: 2-4 hours postdose
|
—
|
—
|
—
|
88.35 ratio
Standard Deviation 5.721
|
88.73 ratio
Standard Deviation 4.517
|
88.16 ratio
Standard Deviation 6.123
|
Adverse Events
IPN60090 20 mg
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
IPN60090 40 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
IPN60090 80 mg
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
IPN60090 120 mg
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
IPN60090 180 mg
Serious events: 4 serious events
Other events: 11 other events
Deaths: 0 deaths
IPN60090 240 mg
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IPN60090 20 mg
n=1 participants at risk
Participants received IPN60090 20 mg capsules orally BID up to Cycle 7 in Part A of the study.
|
IPN60090 40 mg
n=1 participants at risk
Participants received IPN60090 40 mg capsules orally BID up to Cycle 2 in Part A of the study.
|
IPN60090 80 mg
n=1 participants at risk
Participants received IPN60090 80 mg capsules orally BID up to Cycle 5 in Part A of the study.
|
IPN60090 120 mg
n=4 participants at risk
Participants received IPN60090 120 mg capsules orally BID up to Cycle 9 in Part A of the study.
|
IPN60090 180 mg
n=11 participants at risk
Participants received IPN60090 180 mg capsules orally BID up to Cycle 9 in Part A of the study.
|
IPN60090 240 mg
n=4 participants at risk
Participants received IPN60090 240 mg capsules orally BID up to Cycle 4 in Part A of the study.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
9.1%
1/11 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/11 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
25.0%
1/4 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/11 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
25.0%
1/4 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
25.0%
1/4 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/11 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
25.0%
1/4 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/11 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Infections and infestations
Aeromonas infection
|
100.0%
1/1 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/11 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Infections and infestations
COVID-19
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
9.1%
1/11 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/11 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
25.0%
1/4 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Infections and infestations
Cryptosporidiosis infection
|
100.0%
1/1 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/11 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/11 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
25.0%
1/4 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Nervous system disorders
Brain oedema
|
100.0%
1/1 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/11 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
25.0%
1/4 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/11 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Nervous system disorders
Seizure
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/11 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
25.0%
1/4 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
9.1%
1/11 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
50.0%
2/4 • Number of events 2 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
9.1%
1/11 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
9.1%
1/11 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
9.1%
1/11 • Number of events 2 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
100.0%
1/1 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/11 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
9.1%
1/11 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
9.1%
1/11 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
9.1%
1/11 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
9.1%
1/11 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/11 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
25.0%
1/4 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
Other adverse events
| Measure |
IPN60090 20 mg
n=1 participants at risk
Participants received IPN60090 20 mg capsules orally BID up to Cycle 7 in Part A of the study.
|
IPN60090 40 mg
n=1 participants at risk
Participants received IPN60090 40 mg capsules orally BID up to Cycle 2 in Part A of the study.
|
IPN60090 80 mg
n=1 participants at risk
Participants received IPN60090 80 mg capsules orally BID up to Cycle 5 in Part A of the study.
|
IPN60090 120 mg
n=4 participants at risk
Participants received IPN60090 120 mg capsules orally BID up to Cycle 9 in Part A of the study.
|
IPN60090 180 mg
n=11 participants at risk
Participants received IPN60090 180 mg capsules orally BID up to Cycle 9 in Part A of the study.
|
IPN60090 240 mg
n=4 participants at risk
Participants received IPN60090 240 mg capsules orally BID up to Cycle 4 in Part A of the study.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Dysphagia
|
100.0%
1/1 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
9.1%
1/11 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
25.0%
1/4 • Number of events 2 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/11 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
25.0%
1/4 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/11 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
9.1%
1/11 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/11 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
25.0%
1/4 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
9.1%
1/11 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
9.1%
1/11 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
25.0%
1/4 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/11 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
25.0%
1/4 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/11 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
25.0%
1/4 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
27.3%
3/11 • Number of events 11 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
25.0%
1/4 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
100.0%
1/1 • Number of events 2 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
25.0%
1/4 • Number of events 2 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
9.1%
1/11 • Number of events 4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
25.0%
1/4 • Number of events 4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
9.1%
1/11 • Number of events 5 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
25.0%
1/4 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
100.0%
1/1 • Number of events 3 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
9.1%
1/11 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
25.0%
1/4 • Number of events 3 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/11 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/11 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
25.0%
1/4 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/11 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
25.0%
1/4 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
9.1%
1/11 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
25.0%
1/4 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/11 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
9.1%
1/11 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
25.0%
1/4 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/11 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Eye disorders
Photopsia
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
25.0%
1/4 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
45.5%
5/11 • Number of events 6 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
25.0%
1/4 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Eye disorders
Photophobia
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
45.5%
5/11 • Number of events 5 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
50.0%
2/4 • Number of events 2 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Eye disorders
Vision blurred
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
9.1%
1/11 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
25.0%
1/4 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Eye disorders
Visual impairment
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
9.1%
1/11 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/11 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
25.0%
1/4 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
50.0%
2/4 • Number of events 2 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/11 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Nervous system disorders
Migraine with aura
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
9.1%
1/11 • Number of events 2 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
9.1%
1/11 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
100.0%
1/1 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/11 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
9.1%
1/11 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
100.0%
1/1 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/11 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/11 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
25.0%
1/4 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Nervous system disorders
Syncope
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
9.1%
1/11 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Nervous system disorders
Tremor
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
25.0%
1/4 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/11 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
General disorders
Fatigue
|
100.0%
1/1 • Number of events 2 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
25.0%
1/4 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
9.1%
1/11 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
50.0%
2/4 • Number of events 3 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
General disorders
Pyrexia
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
100.0%
1/1 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
100.0%
1/1 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/11 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
25.0%
1/4 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
General disorders
Oedema peripheral
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
100.0%
1/1 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
9.1%
1/11 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
General disorders
Oedema
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
9.1%
1/11 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
General disorders
Peripheral swelling
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
25.0%
1/4 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/11 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
25.0%
1/4 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
9.1%
1/11 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
50.0%
2/4 • Number of events 3 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
100.0%
1/1 • Number of events 2 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/11 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Infections and infestations
Cystitis
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
9.1%
1/11 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Infections and infestations
Oral candidiasis
|
100.0%
1/1 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/11 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/11 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
25.0%
1/4 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Investigations
Aspartate aminotransferase increased
|
100.0%
1/1 • Number of events 2 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
36.4%
4/11 • Number of events 9 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
25.0%
1/4 • Number of events 2 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
9.1%
1/11 • Number of events 2 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
50.0%
2/4 • Number of events 6 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
27.3%
3/11 • Number of events 6 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
9.1%
1/11 • Number of events 7 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
36.4%
4/11 • Number of events 6 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
50.0%
2/4 • Number of events 3 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
9.1%
1/11 • Number of events 5 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/11 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
25.0%
1/4 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
9.1%
1/11 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
100.0%
1/1 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
9.1%
1/11 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
25.0%
1/4 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
9.1%
1/11 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
18.2%
2/11 • Number of events 2 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
9.1%
1/11 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
100.0%
1/1 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/11 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Vascular disorders
Hypertension
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
9.1%
1/11 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
25.0%
1/4 • Number of events 3 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
100.0%
1/1 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
25.0%
1/4 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/11 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/11 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
25.0%
1/4 • Number of events 2 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
100.0%
1/1 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
27.3%
3/11 • Number of events 4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
25.0%
1/4 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
100.0%
1/1 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
100.0%
1/1 • Number of events 2 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/11 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
25.0%
1/4 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
100.0%
1/1 • Number of events 2 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/11 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
25.0%
1/4 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/11 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
9.1%
1/11 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
50.0%
2/4 • Number of events 2 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Psychiatric disorders
Depression
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/11 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
25.0%
1/4 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
9.1%
1/11 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
9.1%
1/11 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
25.0%
1/4 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
9.1%
1/11 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
100.0%
1/1 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/11 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Cardiac disorders
Sinus tachycardia
|
100.0%
1/1 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/11 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
9.1%
1/11 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
9.1%
1/11 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
1/1 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
50.0%
2/4 • Number of events 3 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
27.3%
3/11 • Number of events 3 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
75.0%
3/4 • Number of events 7 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Gastrointestinal disorders
Vomiting
|
100.0%
1/1 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
50.0%
2/4 • Number of events 2 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
9.1%
1/11 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
25.0%
1/4 • Number of events 3 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Gastrointestinal disorders
Abdominal pain
|
100.0%
1/1 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
100.0%
1/1 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
25.0%
1/4 • Number of events 6 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
18.2%
2/11 • Number of events 2 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
25.0%
1/4 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
25.0%
1/4 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
27.3%
3/11 • Number of events 4 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
25.0%
1/4 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Gastrointestinal disorders
Diarrhoea
|
100.0%
1/1 • Number of events 2 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
25.0%
1/4 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
9.1%
1/11 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
25.0%
1/4 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
100.0%
1/1 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
25.0%
1/4 • Number of events 3 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
0.00%
0/11 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
25.0%
1/4 • Number of events 1 • TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
Safety population included all participants who were exposed to (or started receiving) IPN60090.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place