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← JOBEVNE: metastatic cervical cancer

NCT04697628 · STUDY IN CONTEXT

Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer

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

Overall survival is defined as the time from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive.

ITT analysis set included all randomized participants. Participants were included in the treatment group assigned at randomization regardless of any actual treatment received.

→

secondary · POSTED

PFS per investigator was defined as the time from the date of randomization to the first documentation of disease progression (PD) as assessed by investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1, or death due to any cause, whichever occurred earlier. PD: at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). Participants without evidence of radiographic disease progression or death were censored at the date of last adequate tumor assessment prior to data cut-off date or start of new anti-cancer therapy. Participants with disease progression or death that occurred after 2 or more missed scans were censored at the last adequate tumor assessment prior to missed scans. Participants without post-baseline scan data were censored at the day of randomization.

ITT analysis set included all randomized participants. Participants were included in the treatment group assigned at randomization regardless of any actual treatment received.

→

secondary · POSTED

Confirmed objective response rate was defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) per RECIST v.1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. PR was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The minimum criteria for stable disease (SD) duration are defined as ≥ 5 weeks after the date of randomization. For a response to be considered as confirmed, the subsequent response had to be at least 4 weeks after the initial response. Two-sided 95% exact confidence interval (CI) was computed using the Clopper-Pearson method.

ITT analysis set included all randomized participants. Participants were included in the treatment group assigned at randomization regardless of any actual treatment received.

→

secondary · POSTED

TTR was defined as the time from the randomization date to the date of the first confirmed objective response (CR or PR that was subsequently confirmed). CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. PR was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

ITT analysis set included all randomized participants. Participants were included in the treatment group assigned at randomization regardless of any actual treatment received. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Only participants who achieved a confirmed CR or PR based on investigator assessment were included in the analysis.

→

secondary · POSTED

DOR was defined as the time from the date of the first confirmed objective response (CR or PR that was subsequently confirmed) to the date of the first documented PD per RECIST v1.1 or death from any cause, whichever occurred first. CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. PR was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

ITT analysis set included all randomized participants. Participants were included in the treatment group assigned at randomization regardless of any actual treatment received. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Only participants who achieved a confirmed CR or PR based on investigator assessment were included in the analysis.

→

secondary · POSTED

An AE was any untoward medical occurrence in a clinical study participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.. TEAE was defined as a newly occurring or worsening AE after the first dose of study treatment and with onset date on or before 30 days after the last dose of study treatment.

Safety analysis set included all randomized participants who received at least 1 dose of study treatment (tisotumab vedotin or chemotherapy).

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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

EQ-5D · EuroQOL Five Dimensions Five Level (EQ-5D-5L) Index Score

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-jobevne-5a0678d2
nct id
NCT04697628
qol key
qol-0006
source section id
NCT04697628-om-0006
source outcome index
6
instrument
EQ-5D
instrument basis
matched 'eq-5d' in the study's own wording
scale title
EuroQOL Five Dimensions Five Level (EQ-5D-5L) Index Score
measure definition
The EQ-5D-5L questionnaire is a 5-item self-reported measure of functioning and well-being, which assesses 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension comprises 5 levels (no problems, slight problems, moderate problems, severe problems and extreme problems). Responses to the 5 items are then converted to a weighted health state index (utility score) based on values derived from general population samples. This health utility score is between 0 and 1, where 0 is death and 1 is perfect health.
time frame
From start of treatment until end of follow-up
analysis role
secondary
reporting status
NOT_POSTED
higher is better
Source null
direction quote
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EQ-5D · EQ-5D Visual Analog Scale (VAS) Scores

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-jobevne-5a0678d2
nct id
NCT04697628
qol key
qol-0007
source section id
NCT04697628-om-0007
source outcome index
7
instrument
EQ-5D
instrument basis
matched 'eq-5d' in the study's own wording
scale title
EQ-5D Visual Analog Scale (VAS) Scores
measure definition
EQ5D is a participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state) ; higher scores indicate a better health state.
time frame
From start of treatment until end of follow-up
analysis role
secondary
reporting status
NOT_POSTED
higher is better
1
direction quote
higher scores indicate a better
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EORTC QLQ · European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Total Score

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-jobevne-5a0678d2
nct id
NCT04697628
qol key
qol-0008
source section id
NCT04697628-om-0008
source outcome index
8
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Total Score
measure definition
The EORTC-QLQ-C30 questionnaire is composed of 30 questions for which the answers ranges either from 1 (not at all) to 4 (very much) for items 1 to 28, or from 1 (very poor) to 7 (excellent) for items 29 to 30. The EORTC QLQ-C30 scale scores will be calculated using the EORTC QLQ-C30 Scoring Manual. These include 5 functional scales, 3 symptom scales, a global health status/QoL scale, and 6 single items. Each of the multi-item scales includes a different set of items (i.e., no item occurs in more than one scale). All of the scales and single-item measures range in score from 0 to 100, with a high scale score representing a higher response level (e.g., a high level of functioning, a high QoL, or a high level of symptomatology/problems)
time frame
From start of treatment until end of follow-up
analysis role
secondary
reporting status
NOT_POSTED
higher is better
Source null
direction quote
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EORTC QLQ · EORTC Quality of Life Questionnaire Cervical Cancer Module (QLQ-CX24) Total Scores

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-jobevne-5a0678d2
nct id
NCT04697628
qol key
qol-0009
source section id
NCT04697628-om-0009
source outcome index
9
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
EORTC Quality of Life Questionnaire Cervical Cancer Module (QLQ-CX24) Total Scores
measure definition
The EORTC QLQ-CX24 questionnaire is meant for use among cervical cancer participants varying in disease stage and treatment modality. The EORTC-QLQ-CX24 questionnaire is composed of 24 questions for which the answers ranged from 1 (Not at all) to 4 (Very much). Four functional scales and 5 symptom scales will be calculated using the EORTC QLQ-CX24 Scoring Manual. The 9 scores computed from the EORTC-QLQ-CX24 questionnaire will be summarized by treatment arm using descriptive statistics.
time frame
From start of treatment until end of follow-up
analysis role
secondary
reporting status
NOT_POSTED
higher is better
Source null
direction quote
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-jobevne-5a0678d2
nct id
NCT04697628
trial label
Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer
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
2
qol Count
4
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer-jobevne-5a0678d2
    nct id
    NCT04697628
    outcome key
    om-0000
    source section id
    NCT04697628-om-0000
    source outcome index
    0
    endpoint
    Overall Survival
    endpoint definition
    Overall survival is defined as the time from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive.
    time origin
    From randomization to date of death due to any cause or censoring date, whichever occurred first (maximum up to 25 months)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT analysis set included all randomized participants. Participants were included in the treatment group assigned at randomization regardless of any actual treatment received.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer-jobevne-5a0678d2
    nct id
    NCT04697628
    outcome key
    om-0001
    source section id
    NCT04697628-om-0001
    source outcome index
    1
    endpoint
    Progression Free Survival (PFS) as Assessed by Investigator
    endpoint definition
    PFS per investigator was defined as the time from the date of randomization to the first documentation of disease progression (PD) as assessed by investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1, or death due to any cause, whichever occurred earlier. PD: at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). Participants without evidence of radiographic disease progression or death were censored at the date of last adequate tumor assessment prior to data cut-off date or start of new anti-cancer therapy. Participants with disease progression or death that occurred after 2 or more missed scans were censored at the last adequate tumor assessment prior to missed scans. Participants without post-baseline scan data were censored at the day of randomization.
    time origin
    From the date of randomization to first documentation of PD or death due to any cause, or censoring date whichever occurred first (maximum up to 25 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT analysis set included all randomized participants. Participants were included in the treatment group assigned at randomization regardless of any actual treatment received.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer-jobevne-5a0678d2
    nct id
    NCT04697628
    outcome key
    om-0002
    source section id
    NCT04697628-om-0002
    source outcome index
    2
    endpoint
    Confirmed Objective Response Rate (ORR) as Assessed by Investigator
    endpoint definition
    Confirmed objective response rate was defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) per RECIST v.1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. PR was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The minimum criteria for stable disease (SD) duration are defined as ≥ 5 weeks after the date of randomization. For a response to be considered as confirmed, the subsequent response had to be at least 4 weeks after the initial response. Two-sided 95% exact confidence interval (CI) was computed using the Clopper-Pearson method.
    time origin
    From the date of randomization until date of confirmed CR or PR (maximum up to 25 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT analysis set included all randomized participants. Participants were included in the treatment group assigned at randomization regardless of any actual treatment received.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer-jobevne-5a0678d2
    nct id
    NCT04697628
    outcome key
    om-0003
    source section id
    NCT04697628-om-0003
    source outcome index
    3
    endpoint
    Time-to-Response (TTR) as Assessed by the Investigator
    endpoint definition
    TTR was defined as the time from the randomization date to the date of the first confirmed objective response (CR or PR that was subsequently confirmed). CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. PR was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
    time origin
    From the date of randomization to date of date of the first confirmed objective response (maximum up to 25 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT analysis set included all randomized participants. Participants were included in the treatment group assigned at randomization regardless of any actual treatment received. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Only participants who achieved a confirmed CR or PR based on investigator assessment were included in the analysis.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer-jobevne-5a0678d2
    nct id
    NCT04697628
    outcome key
    om-0004
    source section id
    NCT04697628-om-0004
    source outcome index
    4
    endpoint
    Duration of Response (DOR) by Investigator Assessment
    endpoint definition
    DOR was defined as the time from the date of the first confirmed objective response (CR or PR that was subsequently confirmed) to the date of the first documented PD per RECIST v1.1 or death from any cause, whichever occurred first. CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. PR was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
    time origin
    From the date of first documented response of CR or PR to the first documented PD or death from any cause, whichever occurred first (maximum up to 25 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT analysis set included all randomized participants. Participants were included in the treatment group assigned at randomization regardless of any actual treatment received. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Only participants who achieved a confirmed CR or PR based on investigator assessment were included in the analysis.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer-jobevne-5a0678d2
    nct id
    NCT04697628
    outcome key
    om-0005
    source section id
    NCT04697628-om-0005
    source outcome index
    5
    endpoint
    Number of Participants With Treatment Emergent Adverse Events (TEAEs)
    endpoint definition
    An AE was any untoward medical occurrence in a clinical study participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.. TEAE was defined as a newly occurring or worsening AE after the first dose of study treatment and with onset date on or before 30 days after the last dose of study treatment.
    time origin
    From start of treatment up to 30 days after last dose of study treatment (up to 25 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Safety analysis set included all randomized participants who received at least 1 dose of study treatment (tisotumab vedotin or chemotherapy).
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer-jobevne-5a0678d2
    nct id
    NCT04697628
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Tisotumab Vedotin
    regimen
    Participants with rCC/mCC were administered tisotumab vedotin 2.0 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once every 3 weeks (Q3W).
    analyzed count
    253
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04697628-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer-jobevne-5a0678d2
    nct id
    NCT04697628
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Chemotherapy
    regimen
    Participants with rCC/mCC were treated with investigator's choice of chemotherapy which included either topotecan 1 or 1.25 milligram per meter square \[mg/m\^2\] IV on Days 1 to 5, every 21 days or vinorelbine 30 mg/m\^2 IV on Days 1 and 8, every 21 days or gemcitabine 1000 mg/m\^2 IV on Days 1 and 8, every 21 days or irinotecan 100 or 125 mg/m\^2 IV weekly for 28 days, every 42 days or pemetrexed 500 mg/m\^2 on Day 1, every 21 days.
    analyzed count
    249
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04697628-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer-jobevne-5a0678d2
    nct id
    NCT04697628
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Tisotumab Vedotin
    regimen
    Participants with rCC/mCC were administered tisotumab vedotin 2.0 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once every 3 weeks (Q3W).
    analyzed count
    253
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04697628-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer-jobevne-5a0678d2
    nct id
    NCT04697628
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Chemotherapy
    regimen
    Participants with rCC/mCC were treated with investigator's choice of chemotherapy which included either topotecan 1 or 1.25 milligram per meter square \[mg/m\^2\] IV on Days 1 to 5, every 21 days or vinorelbine 30 mg/m\^2 IV on Days 1 and 8, every 21 days or gemcitabine 1000 mg/m\^2 IV on Days 1 and 8, every 21 days or irinotecan 100 or 125 mg/m\^2 IV weekly for 28 days, every 42 days or pemetrexed 500 mg/m\^2 on Day 1, every 21 days.
    analyzed count
    249
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04697628-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer-jobevne-5a0678d2
    nct id
    NCT04697628
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Tisotumab Vedotin
    regimen
    Participants with rCC/mCC were administered tisotumab vedotin 2.0 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once every 3 weeks (Q3W).
    analyzed count
    253
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04697628-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer-jobevne-5a0678d2
    nct id
    NCT04697628
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Chemotherapy
    regimen
    Participants with rCC/mCC were treated with investigator's choice of chemotherapy which included either topotecan 1 or 1.25 milligram per meter square \[mg/m\^2\] IV on Days 1 to 5, every 21 days or vinorelbine 30 mg/m\^2 IV on Days 1 and 8, every 21 days or gemcitabine 1000 mg/m\^2 IV on Days 1 and 8, every 21 days or irinotecan 100 or 125 mg/m\^2 IV weekly for 28 days, every 42 days or pemetrexed 500 mg/m\^2 on Day 1, every 21 days.
    analyzed count
    249
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04697628-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer-jobevne-5a0678d2
    nct id
    NCT04697628
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Tisotumab Vedotin
    regimen
    Participants with rCC/mCC were administered tisotumab vedotin 2.0 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once every 3 weeks (Q3W).
    analyzed count
    45
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04697628-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer-jobevne-5a0678d2
    nct id
    NCT04697628
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Chemotherapy
    regimen
    Participants with rCC/mCC were treated with investigator's choice of chemotherapy which included either topotecan 1 or 1.25 milligram per meter square \[mg/m\^2\] IV on Days 1 to 5, every 21 days or vinorelbine 30 mg/m\^2 IV on Days 1 and 8, every 21 days or gemcitabine 1000 mg/m\^2 IV on Days 1 and 8, every 21 days or irinotecan 100 or 125 mg/m\^2 IV weekly for 28 days, every 42 days or pemetrexed 500 mg/m\^2 on Day 1, every 21 days.
    analyzed count
    13
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04697628-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer-jobevne-5a0678d2
    nct id
    NCT04697628
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Tisotumab Vedotin
    regimen
    Participants with rCC/mCC were administered tisotumab vedotin 2.0 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once every 3 weeks (Q3W).
    analyzed count
    45
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04697628-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer-jobevne-5a0678d2
    nct id
    NCT04697628
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Chemotherapy
    regimen
    Participants with rCC/mCC were treated with investigator's choice of chemotherapy which included either topotecan 1 or 1.25 milligram per meter square \[mg/m\^2\] IV on Days 1 to 5, every 21 days or vinorelbine 30 mg/m\^2 IV on Days 1 and 8, every 21 days or gemcitabine 1000 mg/m\^2 IV on Days 1 and 8, every 21 days or irinotecan 100 or 125 mg/m\^2 IV weekly for 28 days, every 42 days or pemetrexed 500 mg/m\^2 on Day 1, every 21 days.
    analyzed count
    13
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04697628-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer-jobevne-5a0678d2
    nct id
    NCT04697628
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Tisotumab Vedotin
    regimen
    Participants with rCC/mCC were administered tisotumab vedotin 2.0 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once every 3 weeks (Q3W).
    analyzed count
    250
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04697628-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer-jobevne-5a0678d2
    nct id
    NCT04697628
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Chemotherapy
    regimen
    Participants with rCC/mCC were treated with investigator's choice of chemotherapy which included either topotecan 1 or 1.25 milligram per meter square \[mg/m\^2\] IV on Days 1 to 5, every 21 days or vinorelbine 30 mg/m\^2 IV on Days 1 and 8, every 21 days or gemcitabine 1000 mg/m\^2 IV on Days 1 and 8, every 21 days or irinotecan 100 or 125 mg/m\^2 IV weekly for 28 days, every 42 days or pemetrexed 500 mg/m\^2 on Day 1, every 21 days.
    analyzed count
    239
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04697628-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer-jobevne-5a0678d2
    nct id
    NCT04697628
    harm key
    EG000
    source section id
    NCT04697628-ae
    event group key
    EG000
    event group label
    Tisotumab Vedotin
    serious affected
    82
    serious at risk
    250
    other affected
    233
    other at risk
    250
    frequency threshold
    5
    collection period
    For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months)
    event definition
    Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer-jobevne-5a0678d2
    nct id
    NCT04697628
    harm key
    EG001
    source section id
    NCT04697628-ae
    event group key
    EG001
    event group label
    Chemotherapy
    serious affected
    94
    serious at risk
    239
    other affected
    223
    other at risk
    239
    frequency threshold
    5
    collection period
    For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months)
    event definition
    Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
    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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer-jobevne-5a0678d2
    nct id
    NCT04697628
    qol key
    qol-0006
    source section id
    NCT04697628-om-0006
    source outcome index
    6
    instrument
    EQ-5D
    instrument basis
    matched 'eq-5d' in the study's own wording
    scale title
    EuroQOL Five Dimensions Five Level (EQ-5D-5L) Index Score
    measure definition
    The EQ-5D-5L questionnaire is a 5-item self-reported measure of functioning and well-being, which assesses 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension comprises 5 levels (no problems, slight problems, moderate problems, severe problems and extreme problems). Responses to the 5 items are then converted to a weighted health state index (utility score) based on values derived from general population samples. This health utility score is between 0 and 1, where 0 is death and 1 is perfect health.
    time frame
    From start of treatment until end of follow-up
    analysis role
    secondary
    reporting status
    NOT_POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer-jobevne-5a0678d2
    nct id
    NCT04697628
    qol key
    qol-0007
    source section id
    NCT04697628-om-0007
    source outcome index
    7
    instrument
    EQ-5D
    instrument basis
    matched 'eq-5d' in the study's own wording
    scale title
    EQ-5D Visual Analog Scale (VAS) Scores
    measure definition
    EQ5D is a participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state) ; higher scores indicate a better health state.
    time frame
    From start of treatment until end of follow-up
    analysis role
    secondary
    reporting status
    NOT_POSTED
    higher is better
    1
    direction quote
    higher scores indicate a better
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer-jobevne-5a0678d2
    nct id
    NCT04697628
    qol key
    qol-0008
    source section id
    NCT04697628-om-0008
    source outcome index
    8
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Total Score
    measure definition
    The EORTC-QLQ-C30 questionnaire is composed of 30 questions for which the answers ranges either from 1 (not at all) to 4 (very much) for items 1 to 28, or from 1 (very poor) to 7 (excellent) for items 29 to 30. The EORTC QLQ-C30 scale scores will be calculated using the EORTC QLQ-C30 Scoring Manual. These include 5 functional scales, 3 symptom scales, a global health status/QoL scale, and 6 single items. Each of the multi-item scales includes a different set of items (i.e., no item occurs in more than one scale). All of the scales and single-item measures range in score from 0 to 100, with a high scale score representing a higher response level (e.g., a high level of functioning, a high QoL, or a high level of symptomatology/problems)
    time frame
    From start of treatment until end of follow-up
    analysis role
    secondary
    reporting status
    NOT_POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer-jobevne-5a0678d2
    nct id
    NCT04697628
    qol key
    qol-0009
    source section id
    NCT04697628-om-0009
    source outcome index
    9
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    EORTC Quality of Life Questionnaire Cervical Cancer Module (QLQ-CX24) Total Scores
    measure definition
    The EORTC QLQ-CX24 questionnaire is meant for use among cervical cancer participants varying in disease stage and treatment modality. The EORTC-QLQ-CX24 questionnaire is composed of 24 questions for which the answers ranged from 1 (Not at all) to 4 (Very much). Four functional scales and 5 symptom scales will be calculated using the EORTC QLQ-CX24 Scoring Manual. The 9 scores computed from the EORTC-QLQ-CX24 questionnaire will be summarized by treatment arm using descriptive statistics.
    time frame
    From start of treatment until end of follow-up
    analysis role
    secondary
    reporting status
    NOT_POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice