Trial Outcomes & Findings for A Clinical Study of Anetumab Ravtansine in Adults With Solid Tumors Who Have Been Treated in Previous Bayer-sponsored Anetumab Ravtansine Studies (NCT NCT03926143)
NCT ID: NCT03926143
Last Updated: 2023-08-04
Results Overview
Treatment emergent adverse events (TEAEs) were defined as AEs starting or worsening during the treatment period. The treatment period extended from the first date of study treatment in this study until the safety follow-up (30 days after the last administration of study treatment). TESAEs: Treatment emergent serious adverse events.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
Approximately 3 years (from first study treatment until safety follow-up)
Results posted on
2023-08-04
Participant Flow
The study was conducted at 7 study centers in 4 countries worldwide between 03-Jun-2019 (first participant first visit) and 18-May-2022 (last participant last visit). Entering participants had to have been treated with anetumab ravtansine in an applicable Bayer sponsored anetumab ravtansine parent study.
A total of 10 participants were screened in this study; of whom 9 participants started study treatment and 1 participant was a screening failure.
Participant milestones
| Measure |
Anetumab Ravtansine
Adult participants with solid tumors who received anetumab-ravtansine treatment as monotherapy, or in combination with gemcitabine in an applicable Bayer-sponsored anetumab ravtansine study.
8 participants received anetumab ravtansine monotherapy and 1 participant received anetumab ravtansine in combination with gemcitabine. Pooled results were reported.
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|---|---|
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Overall Study
STARTED
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9
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Anetumab Ravtansine
Adult participants with solid tumors who received anetumab-ravtansine treatment as monotherapy, or in combination with gemcitabine in an applicable Bayer-sponsored anetumab ravtansine study.
8 participants received anetumab ravtansine monotherapy and 1 participant received anetumab ravtansine in combination with gemcitabine. Pooled results were reported.
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|---|---|
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Overall Study
Physician Decision
|
3
|
|
Overall Study
Subject decision: Covid-19 Pandemic related
|
1
|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Progressive disease
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3
|
Baseline Characteristics
A Clinical Study of Anetumab Ravtansine in Adults With Solid Tumors Who Have Been Treated in Previous Bayer-sponsored Anetumab Ravtansine Studies
Baseline characteristics by cohort
| Measure |
Anetumab Ravtansine
n=9 Participants
Adult participants with solid tumors who received anetumab-ravtansine treatment as monotherapy, or in combination with gemcitabine in an applicable Bayer-sponsored anetumab ravtansine study.
8 participants received anetumab ravtansine monotherapy and 1 participant received anetumab ravtansine in combination with gemcitabine. Pooled results were reported.
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|---|---|
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Age, Continuous
|
50.7 years
STANDARD_DEVIATION 16.2 • n=99 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Ethnicity
Unknown or Not Reported
|
9 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Approximately 3 years (from first study treatment until safety follow-up)Treatment emergent adverse events (TEAEs) were defined as AEs starting or worsening during the treatment period. The treatment period extended from the first date of study treatment in this study until the safety follow-up (30 days after the last administration of study treatment). TESAEs: Treatment emergent serious adverse events.
Outcome measures
| Measure |
Anetumab Ravtansine
n=9 Participants
Adult participants with solid tumors who received anetumab-ravtansine treatment as monotherapy, or in combination with gemcitabine in an applicable Bayer-sponsored anetumab ravtansine study.
8 participants received anetumab ravtansine monotherapy and 1 participant received anetumab ravtansine in combination with gemcitabine. Pooled results were reported.
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|---|---|
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Number of Participants With TEAEs, TESAEs and Drug-related TEAEs and TESAEs
Any TEAE
|
9 Participants
|
|
Number of Participants With TEAEs, TESAEs and Drug-related TEAEs and TESAEs
Serious TEAE
|
2 Participants
|
|
Number of Participants With TEAEs, TESAEs and Drug-related TEAEs and TESAEs
Any study drug-related TEAE
|
8 Participants
|
|
Number of Participants With TEAEs, TESAEs and Drug-related TEAEs and TESAEs
Any study drug-related Serious TEAE
|
0 Participants
|
SECONDARY outcome
Timeframe: Approximately 3 years (from first study treatment until safety follow-up)Overall survival (OS) defined as the time from first treatment in this study until death from any cause. Data on survival were collected by the site. Time frame was reduced due to early termination of the study. Table reports Kaplan-Meier median with Brookmeyer-Crowley confidence intervals. Number (%) of participants with event: 5 (55.6%) and Number (%) of participants censored: 4 (44.4%).
Outcome measures
| Measure |
Anetumab Ravtansine
n=9 Participants
Adult participants with solid tumors who received anetumab-ravtansine treatment as monotherapy, or in combination with gemcitabine in an applicable Bayer-sponsored anetumab ravtansine study.
8 participants received anetumab ravtansine monotherapy and 1 participant received anetumab ravtansine in combination with gemcitabine. Pooled results were reported.
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|---|---|
|
Overall Survival
25th percentile
|
17.6 Months
Interval 6.9 to 34.1
|
|
Overall Survival
Median
|
34.1 Months
Interval 6.9 to
"Not applicable" indicates value cannot be estimated due to censored data.
|
|
Overall Survival
75th percentile
|
NA Months
Interval 28.5 to
"Not applicable" indicates value cannot be estimated due to censored data.
|
Adverse Events
Anetumab Ravtansine
Serious events: 2 serious events
Other events: 9 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Anetumab Ravtansine
n=9 participants at risk
Adult participants with solid tumors who received anetumab-ravtansine treatment as monotherapy, or in combination with gemcitabine in an applicable Bayer-sponsored anetumab ravtansine study.
8 participants received anetumab ravtansine monotherapy and 1 participant received anetumab ravtansine in combination with gemcitabine. Pooled results were reported.
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|---|---|
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Cardiac disorders
Restrictive cardiomyopathy
|
11.1%
1/9 • Number of events 2 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
|
General disorders
Oedema peripheral
|
11.1%
1/9 • Number of events 1 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
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Infections and infestations
Urosepsis
|
11.1%
1/9 • Number of events 1 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
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Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.1%
1/9 • Number of events 1 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
Other adverse events
| Measure |
Anetumab Ravtansine
n=9 participants at risk
Adult participants with solid tumors who received anetumab-ravtansine treatment as monotherapy, or in combination with gemcitabine in an applicable Bayer-sponsored anetumab ravtansine study.
8 participants received anetumab ravtansine monotherapy and 1 participant received anetumab ravtansine in combination with gemcitabine. Pooled results were reported.
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|---|---|
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Blood and lymphatic system disorders
Anaemia
|
55.6%
5/9 • Number of events 10 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
|
Blood and lymphatic system disorders
Leukopenia
|
11.1%
1/9 • Number of events 1 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
11.1%
1/9 • Number of events 1 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
|
Blood and lymphatic system disorders
Neutropenia
|
11.1%
1/9 • Number of events 3 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.1%
1/9 • Number of events 3 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
|
Cardiac disorders
Pericardial effusion
|
11.1%
1/9 • Number of events 1 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
|
Cardiac disorders
Restrictive cardiomyopathy
|
11.1%
1/9 • Number of events 2 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
|
Cardiac disorders
Sinus tachycardia
|
11.1%
1/9 • Number of events 1 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
|
Endocrine disorders
Hyperthyroidism
|
11.1%
1/9 • Number of events 1 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
|
Eye disorders
Cataract
|
11.1%
1/9 • Number of events 1 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
|
Eye disorders
Keratitis
|
11.1%
1/9 • Number of events 1 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
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|
Eye disorders
Vision blurred
|
11.1%
1/9 • Number of events 1 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
|
Eye disorders
Corneal disorder
|
11.1%
1/9 • Number of events 1 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
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|
Eye disorders
Corneal epithelial microcysts
|
22.2%
2/9 • Number of events 2 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
11.1%
1/9 • Number of events 1 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
1/9 • Number of events 2 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
|
Gastrointestinal disorders
Constipation
|
11.1%
1/9 • Number of events 1 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.1%
1/9 • Number of events 2 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
|
Gastrointestinal disorders
Nausea
|
11.1%
1/9 • Number of events 1 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
|
Gastrointestinal disorders
Toothache
|
11.1%
1/9 • Number of events 1 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
|
General disorders
Asthenia
|
22.2%
2/9 • Number of events 2 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
|
General disorders
Chest pain
|
11.1%
1/9 • Number of events 1 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
|
General disorders
Fatigue
|
11.1%
1/9 • Number of events 1 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
|
General disorders
Oedema peripheral
|
22.2%
2/9 • Number of events 3 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
|
Infections and infestations
Conjunctivitis
|
11.1%
1/9 • Number of events 2 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
|
Infections and infestations
Sinusitis
|
11.1%
1/9 • Number of events 1 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
|
Infections and infestations
Skin infection
|
11.1%
1/9 • Number of events 1 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
11.1%
1/9 • Number of events 1 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
11.1%
1/9 • Number of events 1 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
11.1%
1/9 • Number of events 1 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
|
Investigations
Amylase increased
|
22.2%
2/9 • Number of events 3 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
|
Investigations
Aspartate aminotransferase increased
|
11.1%
1/9 • Number of events 3 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
|
Investigations
Blood bilirubin increased
|
11.1%
1/9 • Number of events 1 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
|
Investigations
Blood creatinine increased
|
11.1%
1/9 • Number of events 2 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
11.1%
1/9 • Number of events 1 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
|
Investigations
Lipase increased
|
22.2%
2/9 • Number of events 3 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
|
Investigations
Neutrophil count decreased
|
11.1%
1/9 • Number of events 2 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
|
Investigations
Weight decreased
|
11.1%
1/9 • Number of events 4 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
|
Investigations
Transaminases increased
|
11.1%
1/9 • Number of events 1 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
|
Investigations
Schirmer's test abnormal
|
11.1%
1/9 • Number of events 1 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
|
Investigations
Blood alkaline phosphatase increased
|
22.2%
2/9 • Number of events 6 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
|
Metabolism and nutrition disorders
Cachexia
|
11.1%
1/9 • Number of events 1 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
22.2%
2/9 • Number of events 2 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
11.1%
1/9 • Number of events 1 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
22.2%
2/9 • Number of events 2 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
1/9 • Number of events 1 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
11.1%
1/9 • Number of events 1 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.1%
1/9 • Number of events 1 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
11.1%
1/9 • Number of events 1 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
|
Nervous system disorders
Neuropathy peripheral
|
11.1%
1/9 • Number of events 1 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
22.2%
2/9 • Number of events 6 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
22.2%
2/9 • Number of events 2 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.1%
1/9 • Number of events 2 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.1%
1/9 • Number of events 1 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
11.1%
1/9 • Number of events 1 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
11.1%
1/9 • Number of events 1 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
11.1%
1/9 • Number of events 1 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
11.1%
1/9 • Number of events 1 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
|
Vascular disorders
Hypotension
|
11.1%
1/9 • Number of events 1 • For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER