Tisotumab Vedotin (HuMax®-TF-ADC) Safety Study in Patients With Solid Tumors

Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

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

Evaluation of treatment-emergent adverse events (TEAEs) includes number of participants with at least one: TEAE Serious TEAE Infusion-related TEAE Common Terminology Criteria for Adverse Events (CTCAE) grade \>=3 Treatment-related TEAE A CTCAE TEAE was determined using the CTCAE grading systems based on National Cancer Institute (NCI)-CTCAE version 4.03 assessed by the investigator per the below definitions. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE.

Source null

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secondary · POSTED

Number of participants with markedly abnormal hematology values was defined as all participants who experienced at least 1 CTCAE grade \>= 3 hematology value. A markedly abnormal hematology value was determined using the CTCAE grading systems based on National Cancer Institute (NCI)-CTCAE version 4.03 assessed by the investigator per the below definitions. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE.

Source null

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secondary · POSTED

Number of participants with markedly abnormal coagulation values was defined as all participants who experienced at least 1 CTCAE grade \>= 3 coagulation value. A markedly abnormal coagulation value was determined using the CTCAE grading systems based on National Cancer Institute (NCI)-CTCAE version 4.03 assessed by the investigator per the below definitions. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE.

Source null

→

secondary · POSTED

Number of participants with markedly abnormal biochemistry results were defined as all participants who experienced at least 1 CTCAE grade \>= 3 biochemistry value. A markedly abnormal biochemistry value was determined using the CTCAE grading systems based on National Cancer Institute (NCI)-CTCAE version 4.03 assessed by the investigator per the below definitions. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE.

Source null

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secondary · POSTED

Dose Escalation and Expansion Parts: Number of Participants Who Experienced a Skin Rash

Source null

→

secondary · POSTED

Bleeding adverse events of special interest included treatment emergent adverse events with preferred terms within the following standardised MedDRA queries (SMQs): Haemorrhage terms, excluding laboratory terms SMQ \[20000039\] (Broad) and Haemorrhage, laboratory terms SMQ \[20000040\] (Narrow). Bleeding adverse events of special interest were evaluated according to the NCI-CTCAE version 4.03. Bleeding events of all grades are included. Grade 1:Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE.

Source null

→

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-prostate-cancer-abiraterone-acetate-159cbe11
nct id: NCT02001623
trial label: Tisotumab Vedotin (HuMax®-TF-ADC) Safety Study in Patients With Solid Tumors
applicability: unclear
applicability note: Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: regulator-cited
discovery note: Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count: 6
harms Count: 15
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer-abiraterone-acetate-159cbe11
nct id
NCT02001623
outcome key
om-0000
source section id
NCT02001623-om-0000
source outcome index
0
endpoint
Dose Escalation Part: Evaluation of Treatment-Emergent Adverse Events
endpoint definition
Evaluation of treatment-emergent adverse events (TEAEs) includes number of participants with at least one: TEAE Serious TEAE Infusion-related TEAE Common Terminology Criteria for Adverse Events (CTCAE) grade \>=3 Treatment-related TEAE A CTCAE TEAE was determined using the CTCAE grading systems based on National Cancer Institute (NCI)-CTCAE version 4.03 assessed by the investigator per the below definitions. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE.
time origin
Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the dose escalation part.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population 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-prostate-cancer-abiraterone-acetate-159cbe11
nct id
NCT02001623
outcome key
om-0001
source section id
NCT02001623-om-0001
source outcome index
1
endpoint
Dose Escalation and Expansion Part: Number of Participants With Markedly Abnormal Hematology Values
endpoint definition
Number of participants with markedly abnormal hematology values was defined as all participants who experienced at least 1 CTCAE grade \>= 3 hematology value. A markedly abnormal hematology value was determined using the CTCAE grading systems based on National Cancer Institute (NCI)-CTCAE version 4.03 assessed by the investigator per the below definitions. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE.
time origin
Day 1 to end of follow-up, up to a maximum of 60 weeks
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population 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-prostate-cancer-abiraterone-acetate-159cbe11
nct id
NCT02001623
outcome key
om-0002
source section id
NCT02001623-om-0002
source outcome index
2
endpoint
Dose Escalation and Expansion Parts: Number of Participants With Markedly Abnormal Coagulation Values
endpoint definition
Number of participants with markedly abnormal coagulation values was defined as all participants who experienced at least 1 CTCAE grade \>= 3 coagulation value. A markedly abnormal coagulation value was determined using the CTCAE grading systems based on National Cancer Institute (NCI)-CTCAE version 4.03 assessed by the investigator per the below definitions. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE.
time origin
Day 1 to end of follow-up, up to a maximum of 60 weeks
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population 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-prostate-cancer-abiraterone-acetate-159cbe11
nct id
NCT02001623
outcome key
om-0003
source section id
NCT02001623-om-0003
source outcome index
3
endpoint
Dose Escalation and Expansion Part: Number of Participants With Markedly Abnormal Biochemistry Values
endpoint definition
Number of participants with markedly abnormal biochemistry results were defined as all participants who experienced at least 1 CTCAE grade \>= 3 biochemistry value. A markedly abnormal biochemistry value was determined using the CTCAE grading systems based on National Cancer Institute (NCI)-CTCAE version 4.03 assessed by the investigator per the below definitions. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE.
time origin
Day 1 to end of follow-up, up to a maximum of 60 weeks
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population 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-prostate-cancer-abiraterone-acetate-159cbe11
nct id
NCT02001623
outcome key
om-0004
source section id
NCT02001623-om-0004
source outcome index
4
endpoint
Dose Escalation and Expansion Parts: Number of Participants Who Experienced a Skin Rash
endpoint definition
Dose Escalation and Expansion Parts: Number of Participants Who Experienced a Skin Rash
time origin
Day 1 to end of follow-up, up to a maximum of 60 weeks
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population 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-prostate-cancer-abiraterone-acetate-159cbe11
nct id
NCT02001623
outcome key
om-0005
source section id
NCT02001623-om-0005
source outcome index
5
endpoint
Dose Escalation and Expansion Parts: Number of Participants Who Experienced a Bleeding Event of Special Interest
endpoint definition
Bleeding adverse events of special interest included treatment emergent adverse events with preferred terms within the following standardised MedDRA queries (SMQs): Haemorrhage terms, excluding laboratory terms SMQ \[20000039\] (Broad) and Haemorrhage, laboratory terms SMQ \[20000040\] (Narrow). Bleeding adverse events of special interest were evaluated according to the NCI-CTCAE version 4.03. Bleeding events of all grades are included. Grade 1:Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE.
time origin
Day 1 to end of follow-up, up to a maximum of 60 weeks
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
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-prostate-cancer-abiraterone-acetate-159cbe11
nct id
NCT02001623
outcome key
om-0000
arm key
OG000
arm label
Dose Escalation Part: 0.3 mg/kg
regimen
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an intravenous (IV) infusion at a dose of 0.3 mg/kg of body weight.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02001623-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer-abiraterone-acetate-159cbe11
nct id
NCT02001623
outcome key
om-0000
arm key
OG001
arm label
Dose Escalation Part: 0.6 mg/kg
regimen
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.6 mg/kg of body weight.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02001623-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer-abiraterone-acetate-159cbe11
nct id
NCT02001623
outcome key
om-0000
arm key
OG002
arm label
Dose Escalation Part: 0.9 mg/kg
regimen
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.9 mg/kg of body weight.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02001623-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer-abiraterone-acetate-159cbe11
nct id
NCT02001623
outcome key
om-0000
arm key
OG003
arm label
Dose Escalation Part: 1.2 mg/kg
regimen
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.2 mg/kg of body weight.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02001623-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer-abiraterone-acetate-159cbe11
nct id
NCT02001623
outcome key
om-0000
arm key
OG004
arm label
Dose Escalation Part: 1.5 mg/kg
regimen
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.5 mg/kg of body weight.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02001623-om-0000#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer-abiraterone-acetate-159cbe11
nct id
NCT02001623
outcome key
om-0000
arm key
OG005
arm label
Dose Escalation Part: 1.8 mg/kg
regimen
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.8 mg/kg of body weight.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02001623-om-0000#groups/OG005
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer-abiraterone-acetate-159cbe11
nct id
NCT02001623
outcome key
om-0000
arm key
OG006
arm label
Dose Escalation Part: 2.0 mg/kg
regimen
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02001623-om-0000#groups/OG006
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer-abiraterone-acetate-159cbe11
nct id
NCT02001623
outcome key
om-0000
arm key
OG007
arm label
Dose Escalation Part: 2.2 mg/kg
regimen
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.2 mg/kg of body weight.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02001623-om-0000#groups/OG007
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer-abiraterone-acetate-159cbe11
nct id
NCT02001623
outcome key
om-0001
arm key
OG000
arm label
Dose Escalation Part: 0.3 mg/kg
regimen
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an intravenous (IV) infusion at a dose of 0.3 mg/kg of body weight.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02001623-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer-abiraterone-acetate-159cbe11
nct id
NCT02001623
outcome key
om-0001
arm key
OG001
arm label
Dose Escalation Part: 0.6 mg/kg
regimen
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.6 mg/kg of body weight.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02001623-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer-abiraterone-acetate-159cbe11
nct id
NCT02001623
outcome key
om-0001
arm key
OG002
arm label
Dose Escalation Part: 0.9 mg/kg
regimen
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.9 mg/kg of body weight.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02001623-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer-abiraterone-acetate-159cbe11
nct id
NCT02001623
outcome key
om-0001
arm key
OG003
arm label
Dose Escalation Part: 1.2 mg/kg
regimen
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.2 mg/kg of body weight.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02001623-om-0001#groups/OG003

harms

release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer-abiraterone-acetate-159cbe11
nct id
NCT02001623
harm key
EG000
source section id
NCT02001623-ae
event group key
EG000
event group label
Dose Escalation Part: 0.3 mg/kg
serious affected
2
serious at risk
3
other affected
3
other at risk
3
frequency threshold
5
collection period
Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
event definition
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
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-prostate-cancer-abiraterone-acetate-159cbe11
nct id
NCT02001623
harm key
EG001
source section id
NCT02001623-ae
event group key
EG001
event group label
Dose Escalation Part: 0.6 mg/kg
serious affected
1
serious at risk
3
other affected
3
other at risk
3
frequency threshold
5
collection period
Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
event definition
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
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-prostate-cancer-abiraterone-acetate-159cbe11
nct id
NCT02001623
harm key
EG002
source section id
NCT02001623-ae
event group key
EG002
event group label
Dose Escalation Part: 0.9 mg/kg
serious affected
0
serious at risk
3
other affected
3
other at risk
3
frequency threshold
5
collection period
Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
event definition
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
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-prostate-cancer-abiraterone-acetate-159cbe11
nct id
NCT02001623
harm key
EG003
source section id
NCT02001623-ae
event group key
EG003
event group label
Dose Escalation Part: 1.2 mg/kg
serious affected
2
serious at risk
3
other affected
3
other at risk
3
frequency threshold
5
collection period
Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
event definition
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
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-prostate-cancer-abiraterone-acetate-159cbe11
nct id
NCT02001623
harm key
EG004
source section id
NCT02001623-ae
event group key
EG004
event group label
Dose Escalation Part: 1.5 mg/kg
serious affected
2
serious at risk
3
other affected
3
other at risk
3
frequency threshold
5
collection period
Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
event definition
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
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-prostate-cancer-abiraterone-acetate-159cbe11
nct id
NCT02001623
harm key
EG005
source section id
NCT02001623-ae
event group key
EG005
event group label
Dose Escalation Part: 1.8 mg/kg
serious affected
2
serious at risk
3
other affected
3
other at risk
3
frequency threshold
5
collection period
Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
event definition
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
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-prostate-cancer-abiraterone-acetate-159cbe11
nct id
NCT02001623
harm key
EG006
source section id
NCT02001623-ae
event group key
EG006
event group label
Dose Escalation Part: 2.0 mg/kg
serious affected
2
serious at risk
3
other affected
3
other at risk
3
frequency threshold
5
collection period
Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
event definition
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
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-prostate-cancer-abiraterone-acetate-159cbe11
nct id
NCT02001623
harm key
EG007
source section id
NCT02001623-ae
event group key
EG007
event group label
Dose Escalation Part: 2.2 mg/kg
serious affected
4
serious at risk
6
other affected
6
other at risk
6
frequency threshold
5
collection period
Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
event definition
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
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-prostate-cancer-abiraterone-acetate-159cbe11
nct id
NCT02001623
harm key
EG008
source section id
NCT02001623-ae
event group key
EG008
event group label
Dose Expansion Part: Bladder Cancer
serious affected
7
serious at risk
15
other affected
15
other at risk
15
frequency threshold
5
collection period
Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
event definition
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
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-prostate-cancer-abiraterone-acetate-159cbe11
nct id
NCT02001623
harm key
EG009
source section id
NCT02001623-ae
event group key
EG009
event group label
Dose Expansion Part: Cervical Cancer
serious affected
26
serious at risk
55
other affected
55
other at risk
55
frequency threshold
5
collection period
Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
event definition
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
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-prostate-cancer-abiraterone-acetate-159cbe11
nct id
NCT02001623
harm key
EG010
source section id
NCT02001623-ae
event group key
EG010
event group label
Dose Expansion Part: Endometrial Cancer
serious affected
5
serious at risk
14
other affected
14
other at risk
14
frequency threshold
5
collection period
Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
event definition
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
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-prostate-cancer-abiraterone-acetate-159cbe11
nct id
NCT02001623
harm key
EG011
source section id
NCT02001623-ae
event group key
EG011
event group label
Dose Expansion Part: Esophageal Cancer
serious affected
8
serious at risk
15
other affected
15
other at risk
15
frequency threshold
5
collection period
Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
event definition
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
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