NCT01126749 · STUDY IN CONTEXT

Eribulin Mesylate Administered in Combination With Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin Alone as First-Line Therapy for Locally Advanced or Metastatic Bladd

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

DLTs were clinically significant adverse events within 21 days of treatment judged by investigator at least possibly related to treatment. This included greater than or equal to (\>=) Grade 3 (G3) peripheral neuropathy, \>=G3 nausea and vomiting despite optimal anti-emetic treatment, any other non-hematologic toxicity of \>=G3 (except alopecia, single abnormal laboratory values the Investigator judged unlikely related to study therapy, had no clinical correlate, and resolved within 7 days, and hypersensitivity reaction to any of the compounds), Grade 4 neutropenia lasting over 7 days, febrile neutropenia (defined as fever \>=38.5 degrees Celsius with absolute neutrophil count below 1.0\*10\^9 per liter, G3 thrombocytopenia with nontraumatic bleeding (without therapeutic systemic anticoagulation) requiring platelet transfusion, Grade 4 thrombocytopenia (with or without nontraumatic bleeding), any study drug-related death, any other toxicity the dose escalation committee believed to be DLT.

SAS included all participants who were randomized and treated in Phase 1b of this study.

→

primary · POSTED

TEAE was defined as an adverse event that had an onset date, or a worsening in severity on or after the first dose of study drug up to the end of the study. Number of participants with TEAEs were reported based on safety assessments of laboratory tests, physical examination, examining bowel movements, regular measurement of vital signs, eastern cooperative oncology group-performance status and electrocardiogram parameter values. SAE was any untoward medical occurrence that at any dose: resulted in death; life threatening required inpatient hospitalization; resulted in persistent, significant disability; was congenital anomaly/birth defect or medically important due to other reasons than mentioned criteria. Number of participants with TEAEs and SAEs were reported.

SAS included all participants who were randomized and treated in Phase 2 of this study.

→

secondary · POSTED

PFS was defined as the time from the date of randomization until the earlier of the following two events: the date of disease progression (PD) or the date of death based on response evaluation criteria in solid tumor (RECIST) version (v) 1.1. PD was defined as at least a 20 percent (%) increase or 5 millimeter (mm) increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions.

Modified intent-to-treat (MITT) analysis set included all participants who were randomized and received at least one dose of study medication without major protocol eligibility violations. Due to the lack of a clear definition for PFS censoring rules and deviation from the statistical analysis plan relating to interim analyses, the PFS analysis was deemed unreliable and therefore data was not collected and reported.

→

secondary · POSTED

Overall response rate was defined as the percentage of participants with the best confirmed response of complete response (CR) or partial response (PR) based on RECIST v1.1. CR was defined as complete disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline summed longest diameters.

MITT analysis set included all participants who were randomized and received at least one dose of study medication without major protocol eligibility violations.

→

secondary · POSTED

PFS was defined as the time from the date of randomization until the earlier of the following two events: the date of PD or the date of death based on RECIST v1.1. PD was defined as at least a 20% increase or 5 mm increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions.

MITT analysis set included all participants who were randomized and received at least one dose of study medication without major protocol eligibility violations. Due to the lack of a clear definition for PFS censoring rules and deviation from the statistical analysis plan relating to interim analyses, the PFS analysis was deemed unreliable and therefore data was not collected and reported.

→

secondary · POSTED

TTP was defined as the time from the date of randomization until the date of PD based on RECIST v1.1. PD was defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking in reference the smallest summed longest diameters on study (this included the baseline sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. The appearance of 1 or more new lesions was also considered progression.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-bladder-cancer
nct id: NCT01126749
trial label: Eribulin Mesylate Administered in Combination With Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin Alone as First-Line Therapy for Locally Advanced or Metastatic Bladd
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 6
harms Count: 4
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-bladder-cancer
nct id
NCT01126749
outcome key
om-0000
source section id
NCT01126749-om-0000
source outcome index
0
endpoint
Phase 1b: Number of Participants With Dose-limiting Toxicity (DLT) as Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0
endpoint definition
DLTs were clinically significant adverse events within 21 days of treatment judged by investigator at least possibly related to treatment. This included greater than or equal to (\>=) Grade 3 (G3) peripheral neuropathy, \>=G3 nausea and vomiting despite optimal anti-emetic treatment, any other non-hematologic toxicity of \>=G3 (except alopecia, single abnormal laboratory values the Investigator judged unlikely related to study therapy, had no clinical correlate, and resolved within 7 days, and hypersensitivity reaction to any of the compounds), Grade 4 neutropenia lasting over 7 days, febrile neutropenia (defined as fever \>=38.5 degrees Celsius with absolute neutrophil count below 1.0\*10\^9 per liter, G3 thrombocytopenia with nontraumatic bleeding (without therapeutic systemic anticoagulation) requiring platelet transfusion, Grade 4 thrombocytopenia (with or without nontraumatic bleeding), any study drug-related death, any other toxicity the dose escalation committee believed to be DLT.
time origin
Cycle 1 (Cycle length=21 days)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
SAS included all participants who were randomized and treated in Phase 1b of this study.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-bladder-cancer
nct id
NCT01126749
outcome key
om-0001
source section id
NCT01126749-om-0001
source outcome index
1
endpoint
Phase 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
endpoint definition
TEAE was defined as an adverse event that had an onset date, or a worsening in severity on or after the first dose of study drug up to the end of the study. Number of participants with TEAEs were reported based on safety assessments of laboratory tests, physical examination, examining bowel movements, regular measurement of vital signs, eastern cooperative oncology group-performance status and electrocardiogram parameter values. SAE was any untoward medical occurrence that at any dose: resulted in death; life threatening required inpatient hospitalization; resulted in persistent, significant disability; was congenital anomaly/birth defect or medically important due to other reasons than mentioned criteria. Number of participants with TEAEs and SAEs were reported.
time origin
From the first dose of study drug up to approximately 6 years 3 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
SAS included all participants who were randomized and treated in Phase 2 of this study.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-bladder-cancer
nct id
NCT01126749
outcome key
om-0002
source section id
NCT01126749-om-0002
source outcome index
2
endpoint
Phase 2: Progression-free Survival (PFS)
endpoint definition
PFS was defined as the time from the date of randomization until the earlier of the following two events: the date of disease progression (PD) or the date of death based on response evaluation criteria in solid tumor (RECIST) version (v) 1.1. PD was defined as at least a 20 percent (%) increase or 5 millimeter (mm) increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions.
time origin
From the date of randomization until the earlier of the following two events: the date of PD or the date of death (Up to approximately 6 years 3 months)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Modified intent-to-treat (MITT) analysis set included all participants who were randomized and received at least one dose of study medication without major protocol eligibility violations. Due to the lack of a clear definition for PFS censoring rules and deviation from the statistical analysis plan relating to interim analyses, the PFS analysis was deemed unreliable and therefore data was not collected and reported.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-bladder-cancer
nct id
NCT01126749
outcome key
om-0003
source section id
NCT01126749-om-0003
source outcome index
3
endpoint
Phase 2: Percentage of Participants With Overall Response
endpoint definition
Overall response rate was defined as the percentage of participants with the best confirmed response of complete response (CR) or partial response (PR) based on RECIST v1.1. CR was defined as complete disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline summed longest diameters.
time origin
From the date of randomization until CR or PR (Up to approximately 6 years 3 months)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
MITT analysis set included all participants who were randomized and received at least one dose of study medication without major protocol eligibility violations.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-bladder-cancer
nct id
NCT01126749
outcome key
om-0004
source section id
NCT01126749-om-0004
source outcome index
4
endpoint
Phase 2: Percentage of Participants With Progression-free Survival at Week 12
endpoint definition
PFS was defined as the time from the date of randomization until the earlier of the following two events: the date of PD or the date of death based on RECIST v1.1. PD was defined as at least a 20% increase or 5 mm increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions.
time origin
Week 12
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
MITT analysis set included all participants who were randomized and received at least one dose of study medication without major protocol eligibility violations. Due to the lack of a clear definition for PFS censoring rules and deviation from the statistical analysis plan relating to interim analyses, the PFS analysis was deemed unreliable and therefore data was not collected and reported.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-bladder-cancer
nct id
NCT01126749
outcome key
om-0005
source section id
NCT01126749-om-0005
source outcome index
5
endpoint
Phase 2: Time to Progression (TTP)
endpoint definition
TTP was defined as the time from the date of randomization until the date of PD based on RECIST v1.1. PD was defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking in reference the smallest summed longest diameters on study (this included the baseline sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. The appearance of 1 or more new lesions was also considered progression.
time origin
From the date of randomization until the date of PD (Up to approximately 6 years 3 months)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
MITT analysis set included all participants who were randomized and received at least one dose of study medication without major protocol eligibility violations. Due to the lack of a clear definition for PFS censoring rules and deviation from the statistical analysis plan relating to interim analyses, the PFS analysis was deemed unreliable and therefore data was not collected and reported.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-bladder-cancer
nct id
NCT01126749
outcome key
om-0000
arm key
OG000
arm label
Phase 1b: Eribulin Mesylate 0.7 mg/m^2 + Gemcitabine 1000 mg/m^2 + Cisplatin 70 mg/m^2
regimen
Participants received Eribulin Mesylate 0.7 mg/m\^2, as an intravenous infusion on Days 1 and 8 in combination with Gemcitabine 1000 mg/m\^2, as an intravenous infusion on Days 1 and 8 and Cisplatin 70 mg/m\^2, as an intravenous infusion on Day 1 of a 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01126749-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-bladder-cancer
nct id
NCT01126749
outcome key
om-0000
arm key
OG001
arm label
Phase 1b: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2 + Cisplatin 70 mg/m^2
regimen
Participants received Eribulin Mesylate 1.0 mg/m\^2, as an intravenous infusion on Days 1 and 8 in combination with Gemcitabine 1000 mg/m\^2, as an intravenous infusion on Days 1 and 8 and Cisplatin 70 mg/m\^2, as an intravenous infusion on Day 1 of a 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01126749-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-bladder-cancer
nct id
NCT01126749
outcome key
om-0001
arm key
OG000
arm label
Phase 2: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2
regimen
Participants received Eribulin Mesylate 1.0 mg/m\^2 (Recommended Phase 2 dose), as an intravenous infusion on Days 1 and 8 in combination with Gemcitabine 1000 mg/m\^2, as an intravenous infusion on Days 1 and 8 and Cisplatin 70 mg/m\^2, as an intravenous infusion on Day 1 of each 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.
analyzed count
41
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01126749-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-bladder-cancer
nct id
NCT01126749
outcome key
om-0001
arm key
OG001
arm label
Phase 2: Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2
regimen
Participants received Gemcitabine 1000 mg/m\^2, as an intravenous infusion on Days 1 and 8 and cisplatin 70 mg/m\^2, as an intravenous infusion on Day 1 of each 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.
analyzed count
39
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01126749-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-bladder-cancer
nct id
NCT01126749
outcome key
om-0002
arm key
OG000
arm label
Phase 2: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2
regimen
Participants received Eribulin Mesylate 1.0 mg/m\^2 (Recommended Phase 2 dose), as an intravenous infusion on Days 1 and 8 in combination with Gemcitabine 1000 mg/m\^2, as an intravenous infusion on Days 1 and 8 and Cisplatin 70 mg/m\^2, as an intravenous infusion on Day 1 of each 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01126749-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-bladder-cancer
nct id
NCT01126749
outcome key
om-0002
arm key
OG001
arm label
Phase 2: Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2
regimen
Participants received Gemcitabine 1000 mg/m\^2, as an intravenous infusion on Days 1 and 8 and cisplatin 70 mg/m\^2, as an intravenous infusion on Day 1 of each 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01126749-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-bladder-cancer
nct id
NCT01126749
outcome key
om-0003
arm key
OG000
arm label
Phase 2: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2
regimen
Participants received Eribulin Mesylate 1.0 mg/m\^2 (Recommended Phase 2 dose), as an intravenous infusion on Days 1 and 8 in combination with Gemcitabine 1000 mg/m\^2, as an intravenous infusion on Days 1 and 8 and Cisplatin 70 mg/m\^2, as an intravenous infusion on Day 1 of each 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.
analyzed count
40
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01126749-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-bladder-cancer
nct id
NCT01126749
outcome key
om-0003
arm key
OG001
arm label
Phase 2: Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2
regimen
Participants received Gemcitabine 1000 mg/m\^2, as an intravenous infusion on Days 1 and 8 and cisplatin 70 mg/m\^2, as an intravenous infusion on Day 1 of each 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.
analyzed count
39
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01126749-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-bladder-cancer
nct id
NCT01126749
outcome key
om-0004
arm key
OG000
arm label
Phase 2: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2
regimen
Participants received Eribulin Mesylate 1.0 mg/m\^2 (Recommended Phase 2 dose), as an intravenous infusion on Days 1 and 8 in combination with Gemcitabine 1000 mg/m\^2, as an intravenous infusion on Days 1 and 8 and Cisplatin 70 mg/m\^2, as an intravenous infusion on Day 1 of each 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01126749-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-bladder-cancer
nct id
NCT01126749
outcome key
om-0004
arm key
OG001
arm label
Phase 2: Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2
regimen
Participants received Gemcitabine 1000 mg/m\^2, as an intravenous infusion on Days 1 and 8 and cisplatin 70 mg/m\^2, as an intravenous infusion on Day 1 of each 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01126749-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-bladder-cancer
nct id
NCT01126749
outcome key
om-0005
arm key
OG000
arm label
Phase 2: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2
regimen
Participants received Eribulin Mesylate 1.0 mg/m\^2 (Recommended Phase 2 dose), as an intravenous infusion on Days 1 and 8 in combination with Gemcitabine 1000 mg/m\^2, as an intravenous infusion on Days 1 and 8 and Cisplatin 70 mg/m\^2, as an intravenous infusion on Day 1 of each 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01126749-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-bladder-cancer
nct id
NCT01126749
outcome key
om-0005
arm key
OG001
arm label
Phase 2: Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2
regimen
Participants received Gemcitabine 1000 mg/m\^2, as an intravenous infusion on Days 1 and 8 and cisplatin 70 mg/m\^2, as an intravenous infusion on Day 1 of each 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01126749-om-0005#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-bladder-cancer
nct id
NCT01126749
harm key
EG000
source section id
NCT01126749-ae
event group key
EG000
event group label
Phase 1b: Eribulin Mesylate 0.7 mg/m^2 + Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2
serious affected
0
serious at risk
3
other affected
3
other at risk
3
frequency threshold
0
collection period
From the first dose of study drug up to approximately 6 years 3 months
event definition
SAS included all participants who were randomized and treated in this study.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-bladder-cancer
nct id
NCT01126749
harm key
EG001
source section id
NCT01126749-ae
event group key
EG001
event group label
Phase 1b: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2
serious affected
1
serious at risk
6
other affected
6
other at risk
6
frequency threshold
0
collection period
From the first dose of study drug up to approximately 6 years 3 months
event definition
SAS included all participants who were randomized and treated in this study.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-bladder-cancer
nct id
NCT01126749
harm key
EG002
source section id
NCT01126749-ae
event group key
EG002
event group label
Phase 2: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2
serious affected
22
serious at risk
41
other affected
41
other at risk
41
frequency threshold
0
collection period
From the first dose of study drug up to approximately 6 years 3 months
event definition
SAS included all participants who were randomized and treated in this study.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-bladder-cancer
nct id
NCT01126749
harm key
EG003
source section id
NCT01126749-ae
event group key
EG003
event group label
Phase 2: Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2
serious affected
14
serious at risk
39
other affected
38
other at risk
39
frequency threshold
0
collection period
From the first dose of study drug up to approximately 6 years 3 months
event definition
SAS included all participants who were randomized and treated in this study.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice