Trial Outcomes & Findings for A Phase I/II Study to Determine the Maximum Tolerated Dose (MTD) and Safety of CC-4047 (Pomalidomide) Administered in Conjunction With Cisplatin and Etoposide (NCT NCT00537511)
NCT ID: NCT00537511
Last Updated: 2019-11-19
Results Overview
The MTD was defined as the highest dose level at which no more than 1 in 6 participants experienced a dose-limiting toxicity (DLT) during the first 21-day cycle of treatment. The MTD Phase included the Treatment period (Cycle 1: Identification of the MTD) and the Extension period (Cycles 2 to 6: Confirmation of Safety of the MTD). (See Secondary Outcome Measure 2 for data on DLTs.)
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
22 participants
Primary outcome timeframe
Cycle 1 (21 days)
Results posted on
2019-11-19
Participant Flow
Participant milestones
| Measure |
Pomalidomide (Overall)
Oral pomalidomide 1 mg - 5 mg daily (QD) for 14 consecutive days of a 21-day cycle, in combination with intravenous (IV) cisplatin 25 mg/m\^2 and IV etoposide 100 mg/m\^2 on Days 1, 2 and 3 of each cycle during the dose-finding phase (Treatment and Extension Periods; 6 cycles in total). Dose escalation followed a standard phase 1 3+3 design. Participants continuing took only their pomalidomide dose (monotherapy) for an additional 3-week Recovery Period (14 days of consecutive dosing followed by 7 days of no study medication). Participants continuing took oral pomalidomide 5 mg QD as monotherapy for 14 consecutive days of each 21-day cycle until disease progression in the Maintenance Phase.
|
|---|---|
|
Treatment Period (Combination)
STARTED
|
22
|
|
Treatment Period (Combination)
Intent-to-Treat (ITT) Populaton
|
22
|
|
Treatment Period (Combination)
Safety Population
|
22
|
|
Treatment Period (Combination)
COMPLETED
|
17
|
|
Treatment Period (Combination)
NOT COMPLETED
|
5
|
|
Extension Period (Combination)
STARTED
|
17
|
|
Extension Period (Combination)
COMPLETED
|
11
|
|
Extension Period (Combination)
NOT COMPLETED
|
6
|
|
Recovery Period (Monotherapy)
STARTED
|
11
|
|
Recovery Period (Monotherapy)
COMPLETED
|
3
|
|
Recovery Period (Monotherapy)
NOT COMPLETED
|
8
|
|
Maintenance Phase (Monotherapy)
STARTED
|
8
|
|
Maintenance Phase (Monotherapy)
COMPLETED
|
0
|
|
Maintenance Phase (Monotherapy)
NOT COMPLETED
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase I/II Study to Determine the Maximum Tolerated Dose (MTD) and Safety of CC-4047 (Pomalidomide) Administered in Conjunction With Cisplatin and Etoposide
Baseline characteristics by cohort
| Measure |
Pomalidomide (Overall)
n=22 Participants
Oral pomalidomide 1 mg - 5 mg daily (QD) for 14 consecutive days of a 21-day cycle, in combination with intravenous (IV) cisplatin 25 mg/m\^2 and IV etoposide 100 mg/m\^2 on Days 1, 2 and 3 of each cycle during the dose-finding phase (Treatment and Extension Periods; 6 cycles in total). Dose escalation followed a standard phase 1 3+3 design. Participants continuing took only their pomalidomide dose (monotherapy) for an additional 3-week Recovery Period (14 days of consecutive dosing followed by 7 days of no study medication). Participants continuing took oral pomalidomide 5 mg QD as monotherapy for 14 consecutive days of each 21-day cycle until disease progression in the Maintenance Phase.
|
|---|---|
|
Age, Continuous
|
63.9 years
STANDARD_DEVIATION 8.76 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian (White)
|
22 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-caucasian
|
0 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (21 days)Population: Safety Population
The MTD was defined as the highest dose level at which no more than 1 in 6 participants experienced a dose-limiting toxicity (DLT) during the first 21-day cycle of treatment. The MTD Phase included the Treatment period (Cycle 1: Identification of the MTD) and the Extension period (Cycles 2 to 6: Confirmation of Safety of the MTD). (See Secondary Outcome Measure 2 for data on DLTs.)
Outcome measures
| Measure |
Pomalidomide (Overall)
n=22 Participants
Oral pomalidomide 1 mg - 5 mg daily (QD) for 14 consecutive days of a 21-day cycle, in combination with intravenous (IV) cisplatin 25 mg/m\^2 and IV etoposide 100 mg/m\^2 on Days 1, 2 and 3 of each cycle during the dose-finding phase (Treatment and Extension Periods; 6 cycles in total). Dose escalation followed a standard phase 1 3+3 design. Participants continuing took only their pomalidomide dose (monotherapy) for an additional 3-week Recovery Period (14 days of consecutive dosing followed by 7 days of no study medication). Participants continuing took oral pomalidomide 5 mg QD as monotherapy for 14 consecutive days of each 21-day cycle until disease progression in the Maintenance Phase.
|
Pomalidomide 3 mg
Oral pomalidomide 3 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m\^2 and etoposide 100 mg/m\^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
|
Pomalidomide 4 mg
Oral pomalidomide 4 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m\^2 and etoposide 100 mg/m\^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
|
Pomalidomide 5 mg
Oral pomalidomide 5 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m\^2 and etoposide 100 mg/m\^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
|
Pomalidomide (Overall, MTD Phase)
Participants received daily oral pomalidomide 1 mg to 5 mg for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m\^2 and etoposide 100 mg/m\^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
|
|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD)
|
4 mg
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycles 1 - 6 (21-day cycles)Population: Safety Population
For the purposes of determining the MTD (see Primary Outcome Measure), a DLT was defined as any 1 or more of the following: inability to deliver all 3 doses of cisplatin and etoposide due to toxicity; inability to deliver 14 consecutive days of daily pomalidomide dosing because the participant did not tolerate the medication due to any of the following: ≥ grade 3 non-hematological toxicity (excluding alopecia) occurring before Day 14 of pomalidomide dosing; febrile neutropenia (absolute neutrophil count \[ANC\] \<1,000/µL and fever \>101ºF, core temperature); grade 4 neutropenia of ≥7 days duration with onset on or before Day 14 of pomalidomide dosing; platelet count \<25,000/µL occurring before Day 14 of pomalidomide dosing. National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), Version 4.0, grades: 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death.
Outcome measures
| Measure |
Pomalidomide (Overall)
n=6 Participants
Oral pomalidomide 1 mg - 5 mg daily (QD) for 14 consecutive days of a 21-day cycle, in combination with intravenous (IV) cisplatin 25 mg/m\^2 and IV etoposide 100 mg/m\^2 on Days 1, 2 and 3 of each cycle during the dose-finding phase (Treatment and Extension Periods; 6 cycles in total). Dose escalation followed a standard phase 1 3+3 design. Participants continuing took only their pomalidomide dose (monotherapy) for an additional 3-week Recovery Period (14 days of consecutive dosing followed by 7 days of no study medication). Participants continuing took oral pomalidomide 5 mg QD as monotherapy for 14 consecutive days of each 21-day cycle until disease progression in the Maintenance Phase.
|
Pomalidomide 3 mg
n=4 Participants
Oral pomalidomide 3 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m\^2 and etoposide 100 mg/m\^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
|
Pomalidomide 4 mg
n=6 Participants
Oral pomalidomide 4 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m\^2 and etoposide 100 mg/m\^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
|
Pomalidomide 5 mg
n=6 Participants
Oral pomalidomide 5 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m\^2 and etoposide 100 mg/m\^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
|
Pomalidomide (Overall, MTD Phase)
Participants received daily oral pomalidomide 1 mg to 5 mg for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m\^2 and etoposide 100 mg/m\^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
|
|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLTs) During the MTD Phase
|
1 participants
|
0 participants
|
0 participants
|
2 participants
|
—
|
SECONDARY outcome
Timeframe: Cycles 1 -6 (21-day cycles)Population: ITT population. 'Not Assessed' category includes participants who did not have adequate data for response assessment at baseline and/or post-baseline prior to the use of any non-protocol anti-tumor therapy.
Investigator's best assessment of response based on RECIST criteria during the MTD phase. For target lesions: Complete Response (CR)=Disappearance of all target lesions; Partial Response (PR)=≥30% decrease in sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD; Progressed Disease (PD)=≥20% increase in sum of LD of target lesions taking as reference the smallest sum LD recorded since treatment started or the appearance of ≥1 new lesions; Stable Disease (SD)=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum LD since treatment started. For non-target lesions: CR= Disappearance of all non-target lesions and normalization of tumor marker level; Incomplete Response/SD=Persistence of ≥1 non-target lesions and/or maintenance of tumor marker level above normal limits; PD=Appearance of ≥1 new lesions; unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
Pomalidomide (Overall)
n=6 Participants
Oral pomalidomide 1 mg - 5 mg daily (QD) for 14 consecutive days of a 21-day cycle, in combination with intravenous (IV) cisplatin 25 mg/m\^2 and IV etoposide 100 mg/m\^2 on Days 1, 2 and 3 of each cycle during the dose-finding phase (Treatment and Extension Periods; 6 cycles in total). Dose escalation followed a standard phase 1 3+3 design. Participants continuing took only their pomalidomide dose (monotherapy) for an additional 3-week Recovery Period (14 days of consecutive dosing followed by 7 days of no study medication). Participants continuing took oral pomalidomide 5 mg QD as monotherapy for 14 consecutive days of each 21-day cycle until disease progression in the Maintenance Phase.
|
Pomalidomide 3 mg
n=4 Participants
Oral pomalidomide 3 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m\^2 and etoposide 100 mg/m\^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
|
Pomalidomide 4 mg
n=6 Participants
Oral pomalidomide 4 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m\^2 and etoposide 100 mg/m\^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
|
Pomalidomide 5 mg
n=6 Participants
Oral pomalidomide 5 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m\^2 and etoposide 100 mg/m\^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
|
Pomalidomide (Overall, MTD Phase)
n=22 Participants
Participants received daily oral pomalidomide 1 mg to 5 mg for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m\^2 and etoposide 100 mg/m\^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
|
|---|---|---|---|---|---|
|
Tumor Response Rate According to Response Evaluation Criteria in Solid Tumors (RECIST)
Not Assessed
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Tumor Response Rate According to Response Evaluation Criteria in Solid Tumors (RECIST)
Missing
|
2 participants
|
0 participants
|
2 participants
|
2 participants
|
6 participants
|
|
Tumor Response Rate According to Response Evaluation Criteria in Solid Tumors (RECIST)
Complete Response
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Tumor Response Rate According to Response Evaluation Criteria in Solid Tumors (RECIST)
Partial Response
|
3 participants
|
3 participants
|
2 participants
|
3 participants
|
11 participants
|
|
Tumor Response Rate According to Response Evaluation Criteria in Solid Tumors (RECIST)
No Change/Stable Disease
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Tumor Response Rate According to Response Evaluation Criteria in Solid Tumors (RECIST)
Progressive Disease
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
4 participants
|
SECONDARY outcome
Timeframe: From first Partial Response (PR) or Complete Response (CR) to disease progression (maximum of 19.4 weeks)Population: Number of participants in ITT population who were considered Responders.
Duration of Response was calculated from first Partial Response (PR) or Complete Response (CR) to disease progression. Duration of response was censored at the last date that the participant was known to be progression-free for: 1) participants who had not progressed at the time of analysis; 2) participants who had been removed from the treatment phase prior to documentation of progression.
Outcome measures
| Measure |
Pomalidomide (Overall)
n=11 Participants
Oral pomalidomide 1 mg - 5 mg daily (QD) for 14 consecutive days of a 21-day cycle, in combination with intravenous (IV) cisplatin 25 mg/m\^2 and IV etoposide 100 mg/m\^2 on Days 1, 2 and 3 of each cycle during the dose-finding phase (Treatment and Extension Periods; 6 cycles in total). Dose escalation followed a standard phase 1 3+3 design. Participants continuing took only their pomalidomide dose (monotherapy) for an additional 3-week Recovery Period (14 days of consecutive dosing followed by 7 days of no study medication). Participants continuing took oral pomalidomide 5 mg QD as monotherapy for 14 consecutive days of each 21-day cycle until disease progression in the Maintenance Phase.
|
Pomalidomide 3 mg
Oral pomalidomide 3 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m\^2 and etoposide 100 mg/m\^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
|
Pomalidomide 4 mg
Oral pomalidomide 4 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m\^2 and etoposide 100 mg/m\^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
|
Pomalidomide 5 mg
Oral pomalidomide 5 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m\^2 and etoposide 100 mg/m\^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
|
Pomalidomide (Overall, MTD Phase)
Participants received daily oral pomalidomide 1 mg to 5 mg for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m\^2 and etoposide 100 mg/m\^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
|
|---|---|---|---|---|---|
|
Duration of Response
|
13.2 weeks
Standard Deviation 5.54
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From enrollment through study termination (approximately 35 months)Population: Participants in the ITT population.
Overall Survival was defined as time (in weeks) from enrollment to death. The median is based on Kaplan-Meier estimate, with 95% confidence intervals about the median overall survival. Overall survival was censored at the last time participant was known to be alive for those who were alive at time of analysis.
Outcome measures
| Measure |
Pomalidomide (Overall)
n=22 Participants
Oral pomalidomide 1 mg - 5 mg daily (QD) for 14 consecutive days of a 21-day cycle, in combination with intravenous (IV) cisplatin 25 mg/m\^2 and IV etoposide 100 mg/m\^2 on Days 1, 2 and 3 of each cycle during the dose-finding phase (Treatment and Extension Periods; 6 cycles in total). Dose escalation followed a standard phase 1 3+3 design. Participants continuing took only their pomalidomide dose (monotherapy) for an additional 3-week Recovery Period (14 days of consecutive dosing followed by 7 days of no study medication). Participants continuing took oral pomalidomide 5 mg QD as monotherapy for 14 consecutive days of each 21-day cycle until disease progression in the Maintenance Phase.
|
Pomalidomide 3 mg
Oral pomalidomide 3 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m\^2 and etoposide 100 mg/m\^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
|
Pomalidomide 4 mg
Oral pomalidomide 4 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m\^2 and etoposide 100 mg/m\^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
|
Pomalidomide 5 mg
Oral pomalidomide 5 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m\^2 and etoposide 100 mg/m\^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
|
Pomalidomide (Overall, MTD Phase)
Participants received daily oral pomalidomide 1 mg to 5 mg for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m\^2 and etoposide 100 mg/m\^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
|
|---|---|---|---|---|---|
|
Overall Survival
|
49.6 weeks
Interval 28.0 to 63.9
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycles 1-6 (21-day cycles). Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6).Population: Safety population
Adverse event (AE) = any noxious, unintended, or untoward medical occurrence occurring at any dose that may appear or worsen in a participant during the course of a study, including new intercurrent illness, worsening concomitant illness, injury, or any concomitant impairment of participant's health, including laboratory test values, regardless of etiology. Serious adverse event (SAE) = any AE which: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. TEAE = any AE occurring or worsening on or after the first treatment with any study drug. Related = suspected by investigator to be related to study treatment. National Cancer Institute \[NCI\] Common Toxicity Criteria for Adverse Events \[CTCAE\], Version 4.0, grades: 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, 5 = death.
Outcome measures
| Measure |
Pomalidomide (Overall)
n=6 Participants
Oral pomalidomide 1 mg - 5 mg daily (QD) for 14 consecutive days of a 21-day cycle, in combination with intravenous (IV) cisplatin 25 mg/m\^2 and IV etoposide 100 mg/m\^2 on Days 1, 2 and 3 of each cycle during the dose-finding phase (Treatment and Extension Periods; 6 cycles in total). Dose escalation followed a standard phase 1 3+3 design. Participants continuing took only their pomalidomide dose (monotherapy) for an additional 3-week Recovery Period (14 days of consecutive dosing followed by 7 days of no study medication). Participants continuing took oral pomalidomide 5 mg QD as monotherapy for 14 consecutive days of each 21-day cycle until disease progression in the Maintenance Phase.
|
Pomalidomide 3 mg
n=4 Participants
Oral pomalidomide 3 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m\^2 and etoposide 100 mg/m\^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
|
Pomalidomide 4 mg
n=6 Participants
Oral pomalidomide 4 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m\^2 and etoposide 100 mg/m\^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
|
Pomalidomide 5 mg
n=6 Participants
Oral pomalidomide 5 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m\^2 and etoposide 100 mg/m\^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
|
Pomalidomide (Overall, MTD Phase)
n=22 Participants
Participants received daily oral pomalidomide 1 mg to 5 mg for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m\^2 and etoposide 100 mg/m\^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the MTD (Combination Treatment) Phase
≥1 TEAE
|
6 participants
|
4 participants
|
6 participants
|
6 participants
|
22 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the MTD (Combination Treatment) Phase
≥1 TEAE related to pomalidomide (POM)
|
6 participants
|
4 participants
|
6 participants
|
6 participants
|
22 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the MTD (Combination Treatment) Phase
≥1 TEAE related to cisplatin and/or etoposide(C/E)
|
6 participants
|
4 participants
|
6 participants
|
6 participants
|
22 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the MTD (Combination Treatment) Phase
≥1 Grade 3 or higher (GR3+) TEAE
|
6 participants
|
4 participants
|
6 participants
|
6 participants
|
22 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the MTD (Combination Treatment) Phase
≥1 GR 3+ TEAE related to POM
|
3 participants
|
2 participants
|
4 participants
|
5 participants
|
14 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the MTD (Combination Treatment) Phase
≥1 GR 3+ TEAE related to C/E
|
6 participants
|
3 participants
|
6 participants
|
5 participants
|
20 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the MTD (Combination Treatment) Phase
≥1 Serious TEAE
|
3 participants
|
1 participants
|
3 participants
|
3 participants
|
10 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the MTD (Combination Treatment) Phase
≥1 Serious TEAE related to POM
|
2 participants
|
1 participants
|
1 participants
|
3 participants
|
7 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the MTD (Combination Treatment) Phase
≥1 Serious TEAE related to C/E
|
2 participants
|
1 participants
|
3 participants
|
3 participants
|
9 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the MTD (Combination Treatment) Phase
≥1 TEAE leading to (→) withdrawal of POM
|
2 participants
|
0 participants
|
2 participants
|
2 participants
|
6 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the MTD (Combination Treatment) Phase
≥1 TEAE → withdrawal of C/E
|
2 participants
|
1 participants
|
1 participants
|
2 participants
|
6 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the MTD (Combination Treatment) Phase
≥1 TEAE → dose reduction/interruption of POM
|
5 participants
|
2 participants
|
4 participants
|
4 participants
|
15 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the MTD (Combination Treatment) Phase
≥1 TEAE → dose reduction/interruption of C/E
|
3 participants
|
3 participants
|
3 participants
|
4 participants
|
13 participants
|
SECONDARY outcome
Timeframe: Cycle 7 to discontinuation (21-day cycles). Median (full range) duration of exposure (in weeks) to pomalidomide during Maintenance Phase was 5.0 (1.1, 36.0).Population: Safety population; participants continuing in the Recovery Period and Maintenance Phase.
Adverse event (AE) = any noxious, unintended, or untoward medical occurrence occurring at any dose that may appear or worsen in a participant during the course of a study, including new intercurrent illness, worsening concomitant illness, injury, or any concomitant impairment of participant's health, including laboratory test values, regardless of etiology. TEAE = any AE occurring or worsening on or after the first treatment with any study drug. 'Related' = suspected by investigator to be related to study treatment. National Cancer Institute \[NCI\] Common Toxicity Criteria for Adverse Events \[CTCAE\], Version 4.0, grades: 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, 5 = death.
Outcome measures
| Measure |
Pomalidomide (Overall)
n=11 Participants
Oral pomalidomide 1 mg - 5 mg daily (QD) for 14 consecutive days of a 21-day cycle, in combination with intravenous (IV) cisplatin 25 mg/m\^2 and IV etoposide 100 mg/m\^2 on Days 1, 2 and 3 of each cycle during the dose-finding phase (Treatment and Extension Periods; 6 cycles in total). Dose escalation followed a standard phase 1 3+3 design. Participants continuing took only their pomalidomide dose (monotherapy) for an additional 3-week Recovery Period (14 days of consecutive dosing followed by 7 days of no study medication). Participants continuing took oral pomalidomide 5 mg QD as monotherapy for 14 consecutive days of each 21-day cycle until disease progression in the Maintenance Phase.
|
Pomalidomide 3 mg
Oral pomalidomide 3 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m\^2 and etoposide 100 mg/m\^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
|
Pomalidomide 4 mg
Oral pomalidomide 4 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m\^2 and etoposide 100 mg/m\^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
|
Pomalidomide 5 mg
Oral pomalidomide 5 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m\^2 and etoposide 100 mg/m\^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
|
Pomalidomide (Overall, MTD Phase)
Participants received daily oral pomalidomide 1 mg to 5 mg for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m\^2 and etoposide 100 mg/m\^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Recovery Period or Maintenance (Monotherapy) Phase
≥1 TEAE
|
9 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Recovery Period or Maintenance (Monotherapy) Phase
≥1 TEAE related to pomalidomide (POM)
|
8 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Recovery Period or Maintenance (Monotherapy) Phase
≥1 TEAE related to cisplatin and/or etoposide (C/E
|
7 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Recovery Period or Maintenance (Monotherapy) Phase
≥1 Grade 3 or higher (GR3+) TEAE
|
6 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Recovery Period or Maintenance (Monotherapy) Phase
≥1 GR 3+ TEAE related to POM
|
2 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Recovery Period or Maintenance (Monotherapy) Phase
≥1 GR 3+ TEAE related to C/E
|
2 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Recovery Period or Maintenance (Monotherapy) Phase
≥1 TEAE → dose reduction/interruption of POM
|
2 participants
|
—
|
—
|
—
|
—
|
Adverse Events
Pomalidomide 1 mg
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Pomalidomide 3 mg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Pomalidomide 4 mg
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Pomalidomide 5 mg
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Pomalidomide (Overall)
Serious events: 10 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pomalidomide 1 mg
n=6 participants at risk
Oral pomalidomide 1 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m\^2 and etoposide 100 mg/m\^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
|
Pomalidomide 3 mg
n=4 participants at risk
Oral pomalidomide 3 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m\^2 and etoposide 100 mg/m\^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
|
Pomalidomide 4 mg
n=6 participants at risk
Oral pomalidomide 4 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m\^2 and etoposide 100 mg/m\^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
|
Pomalidomide 5 mg
n=6 participants at risk
Oral pomalidomide 5 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m\^2 and etoposide 100 mg/m\^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
|
Pomalidomide (Overall)
n=22 participants at risk
Oral pomalidomide 1 mg - 5 mg daily (QD) for 14 consecutive days of a 21-day cycle, in combination with intravenous (IV) cisplatin 25 mg/m\^2 and IV etoposide 100 mg/m\^2 on Days 1, 2 and 3 of each cycle during the dose-finding phase (Treatment and Extension Periods; 6 cycles in total). Dose escalation followed a standard phase 1 3+3 design. Participants continuing took only their pomalidomide dose (monotherapy) for an additional 3-week Recovery Period (14 days of consecutive dosing followed by 7 days of no study medication). Participants continuing took oral pomalidomide 5 mg QD as monotherapy for 14 consecutive days of each 21-day cycle until disease progression in the Maintenance Phase.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
25.0%
1/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
9.1%
2/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Cardiac disorders
Atrioventricular Block Complete
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Gastrointestinal disorders
Diverticular Perforation
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
General disorders
Fatigue
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Infections and infestations
Neutropenic Infection
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
9.1%
2/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Infections and infestations
Sepsis
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Nervous system disorders
Cerebral Ischaemia
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Nervous system disorders
Convulsion
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
33.3%
2/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
9.1%
2/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
Other adverse events
| Measure |
Pomalidomide 1 mg
n=6 participants at risk
Oral pomalidomide 1 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m\^2 and etoposide 100 mg/m\^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
|
Pomalidomide 3 mg
n=4 participants at risk
Oral pomalidomide 3 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m\^2 and etoposide 100 mg/m\^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
|
Pomalidomide 4 mg
n=6 participants at risk
Oral pomalidomide 4 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m\^2 and etoposide 100 mg/m\^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
|
Pomalidomide 5 mg
n=6 participants at risk
Oral pomalidomide 5 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m\^2 and etoposide 100 mg/m\^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
|
Pomalidomide (Overall)
n=22 participants at risk
Oral pomalidomide 1 mg - 5 mg daily (QD) for 14 consecutive days of a 21-day cycle, in combination with intravenous (IV) cisplatin 25 mg/m\^2 and IV etoposide 100 mg/m\^2 on Days 1, 2 and 3 of each cycle during the dose-finding phase (Treatment and Extension Periods; 6 cycles in total). Dose escalation followed a standard phase 1 3+3 design. Participants continuing took only their pomalidomide dose (monotherapy) for an additional 3-week Recovery Period (14 days of consecutive dosing followed by 7 days of no study medication). Participants continuing took oral pomalidomide 5 mg QD as monotherapy for 14 consecutive days of each 21-day cycle until disease progression in the Maintenance Phase.
|
|---|---|---|---|---|---|
|
General disorders
Fatigue
|
83.3%
5/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
100.0%
4/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
100.0%
6/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
100.0%
6/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
95.5%
21/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
General disorders
Oedema peripheral
|
33.3%
2/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
25.0%
1/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
50.0%
3/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
50.0%
3/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
40.9%
9/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
General disorders
Asthenia
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
25.0%
1/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
13.6%
3/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
General disorders
Chest discomfort
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
13.6%
3/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
General disorders
Chest pain
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
33.3%
2/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
13.6%
3/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
General disorders
Pyrexia
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
13.6%
3/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
General disorders
Chills
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
9.1%
2/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
General disorders
Irritability
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
9.1%
2/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
General disorders
Face oedema
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
General disorders
Facial pain
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
General disorders
Infusion site reaction
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
General disorders
Injection site reaction
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
General disorders
Mucosal inflammation
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Gastrointestinal disorders
Nausea
|
50.0%
3/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
50.0%
2/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
83.3%
5/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
83.3%
5/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
68.2%
15/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Gastrointestinal disorders
Constipation
|
50.0%
3/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
50.0%
2/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
66.7%
4/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
66.7%
4/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
59.1%
13/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
3/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
33.3%
2/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
27.3%
6/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
2/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
33.3%
2/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
33.3%
2/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
27.3%
6/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
33.3%
2/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
50.0%
3/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
27.3%
6/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
25.0%
1/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
33.3%
2/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
18.2%
4/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Gastrointestinal disorders
Dental discomfort
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Gastrointestinal disorders
Flatulence
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Gastrointestinal disorders
Tooth loss
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
25.0%
1/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
2/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
25.0%
1/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
66.7%
4/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
33.3%
2/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
40.9%
9/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
50.0%
2/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
18.2%
4/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
25.0%
1/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
13.6%
3/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
25.0%
1/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
9.1%
2/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
25.0%
1/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
9.1%
2/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
33.3%
2/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
9.1%
2/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Respiratory, thoracic and mediastinal disorders
Allergic sinusitis
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
25.0%
1/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
33.3%
2/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
75.0%
3/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
33.3%
2/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
33.3%
2/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
40.9%
9/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Nervous system disorders
Dizziness
|
50.0%
3/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
33.3%
2/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
27.3%
6/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Nervous system disorders
Dysgeusia
|
33.3%
2/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
50.0%
2/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
33.3%
2/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
27.3%
6/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
66.7%
4/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
18.2%
4/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Nervous system disorders
Tremor
|
33.3%
2/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
13.6%
3/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Nervous system disorders
Memory impairment
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
25.0%
1/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
9.1%
2/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Nervous system disorders
Apraxia
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Nervous system disorders
Ataxia
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Nervous system disorders
Convulsion
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Nervous system disorders
Lethargy
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Nervous system disorders
Speech disorder
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
50.0%
3/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
75.0%
3/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
83.3%
5/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
54.5%
12/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
25.0%
1/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
50.0%
3/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
33.3%
2/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
31.8%
7/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
25.0%
1/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
33.3%
2/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
22.7%
5/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
33.3%
2/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
13.6%
3/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
9.1%
2/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
25.0%
1/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
9.1%
2/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Skin and subcutaneous tissue disorders
Hypoaesthesia facial
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
2/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
50.0%
2/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
66.7%
4/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
36.4%
8/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
33.3%
2/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
18.2%
4/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
9.1%
2/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
33.3%
2/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
9.1%
2/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
33.3%
2/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
9.1%
2/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
33.3%
2/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
9.1%
2/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
33.3%
2/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
9.1%
2/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
9.1%
2/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
33.3%
2/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
9.1%
2/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Infections and infestations
Rhinitis
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
50.0%
3/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
18.2%
4/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
9.1%
2/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
25.0%
1/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
9.1%
2/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
33.3%
2/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
9.1%
2/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Infections and infestations
Sinusitis
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
25.0%
1/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
9.1%
2/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
25.0%
1/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Infections and infestations
Laryngitis
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Infections and infestations
Infected cyst
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Infections and infestations
Influenza
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Infections and infestations
Mastoiditis
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
25.0%
1/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Infections and infestations
Skin infection
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
25.0%
1/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Blood and lymphatic system disorders
Neutropenia
|
50.0%
3/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
50.0%
2/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
50.0%
3/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
83.3%
5/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
59.1%
13/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
50.0%
2/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
33.3%
2/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
22.7%
5/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Blood and lymphatic system disorders
Anaemia
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Investigations
Haemoglobin decreased
|
33.3%
2/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
50.0%
2/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
33.3%
2/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
50.0%
3/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
40.9%
9/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Investigations
Weight decreased
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
50.0%
2/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
13.6%
3/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Investigations
Blood creatinine increased
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
25.0%
1/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
9.1%
2/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Investigations
Platelet count decreased
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
25.0%
1/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
9.1%
2/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Investigations
Blood potassium decreased
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
25.0%
1/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Investigations
Creatinine renal clearance decreased
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Investigations
Electrocardiogram qt prolonged
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
25.0%
1/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Investigations
Electrocardiogram st-t segment abnormal
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Investigations
Weight increased
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
33.3%
2/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
50.0%
2/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
27.3%
6/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
50.0%
2/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
18.2%
4/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
50.0%
2/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
13.6%
3/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
9.1%
2/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
25.0%
1/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
9.1%
2/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
25.0%
1/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
9.1%
2/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
9.1%
2/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
25.0%
1/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
25.0%
1/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
25.0%
1/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
25.0%
1/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Vascular disorders
Hypotension
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
50.0%
3/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
22.7%
5/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Vascular disorders
Flushing
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
25.0%
1/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
13.6%
3/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Vascular disorders
Phlebitis
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
25.0%
1/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Vascular disorders
Thrombosis
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
25.0%
1/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Psychiatric disorders
Depression
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
25.0%
1/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
18.2%
4/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
25.0%
1/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
33.3%
2/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
18.2%
4/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Psychiatric disorders
Personality change
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Eye disorders
Lacrimation increased
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
25.0%
1/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
9.1%
2/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Eye disorders
Vision blurred
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
9.1%
2/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Eye disorders
Cataract
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Eye disorders
Diplopia
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Eye disorders
Dry eye
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Eye disorders
Eye pain
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
9.1%
2/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Renal and urinary disorders
Urinary incontinence
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
25.0%
1/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
9.1%
2/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
25.0%
1/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
33.3%
2/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
13.6%
3/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
25.0%
1/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
25.0%
1/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
50.0%
2/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
13.6%
3/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Injury, poisoning and procedural complications
Contusion
|
33.3%
2/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
9.1%
2/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Injury, poisoning and procedural complications
Contrast media reaction
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Injury, poisoning and procedural complications
Excoriation
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Immune system disorders
Hypersensitivity
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
25.0%
1/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
9.1%
2/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
25.0%
1/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
|
Additional Information
Associate Director, Clinical Trial Disclosure
Celgene
Phone: 1-888-260-1599
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Upon investigator submission of a publication or presentation to Celgene, Celgene shall complete its review within 60 days after receipt of the proposed publication or presentation. Upon Celgene's request, proposed publication or presentation will be delayed up to 60 additional days to enable Celgene to secure adequate intellectual property protection of property of Celgene that would be affected by such proposed publication or presentation.
- Publication restrictions are in place
Restriction type: OTHER