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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-003171-64 | EudraCT Number |
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The study was terminated because clinical development of depatuxizumab mafodotin in glioblastoma was stopped due to lack of survival benefit.
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The objective of this study was to evaluate the effect of several ophthalmologic prophylactic treatment strategies for the management of ocular side effects (OSEs) in participants with epidermal growth factor receptor (EGFR)-amplified glioblastoma (GBM) who were being treated with depatuxizumab mafodotin (ABT-414).
This Phase 3b open-label, randomized, exploratory study included 2 phases during the treatment period: chemoradiation therapy (radiation plus temozolomide [RT/TMZ]) and adjuvant therapy (TMZ). All participants received depatuxizumab mafodotin during both phases of the treatment period plus 1 of 3 prophylactic ophthalmologic treatments (standard steroids; standard steroids with vasoconstrictors and cold compress; and enhanced steroids with vasoconstrictors and cold compress. The study comprised a screening period of up to 7 weeks after surgery, a 6-week concomitant Chemoradiation Phase, an Adjuvant Phase beginning approximately 4 weeks after completion of chemoradiation, and a Follow-Up Phase.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Steroids | Experimental | Steroid eye drops: 1 drop each eye, 3 times/day, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days |
|
| Standard Steroids + Vasoconstrictor + Cold Compress | Experimental | Steroid eye drops: 1 drop each eye, 3 times/day, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Vasoconstrictor Eye Drops: 1 drop each eye 4 - 6 times on day of infusion in total (5 - 10 minutes before infusion; at end of infusion; and 2 - 4 times during the remainder of the infusion day). Continuing 4 - 6 times/day on Day 1 and Day 2 after each depatuxizumab mafodotin infusion; Cold Compress: Starting 5 minutes prior to start of infusion and continuing for 30 minutes past end of infusion, and then use at least 2 hours total/day on Days 1 - 3 with each depatuxizumab mafodotin infusion. The cold compress was to be applied in increments no longer than 30 min (could be shorter if the participant was uncomfortable). |
|
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Experimental | Enhanced steroid eye drops: 1 drop each eye, 6 times/day, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Ophthalmic Steroid Ointment; applied to each eye once daily before sleep, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Vasoconstrictor Eye Drops: 1 drop each eye 4 - 6 times on day of infusion in total (5 - 10 minutes before infusion; at end of infusion; and 2 - 4 times during the remainder of the infusion day). Continuing 4 - 6 times/day on Day 1 and Day 2 after each depatuxizumab mafodotin infusion; Cold Compress: Starting 5 minutes prior to start of infusion and continuing for 30 minutes past end of infusion, and then use at least 2 hours total/day on Days 1 - 3 with each depatuxizumab mafodotin infusion. Cold compress was to be applied in increments no longer than 30 min (could be shorter if the patient is uncomfortable). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Steroid eye drops | Drug | Solution, eye drop |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Required a Change in Ocular Side Effect (OSE) Management | Inadequate control of ocular side effects (OSE) was defined as either a ≥ 3-line decline from baseline (≥ +0.3 on LogMAR scale) in visual acuity (with baseline correction determined at the screening ophthalmology visit)) or ≥ Grade 3 OSE severity on the Corneal Epithelial Adverse Event (CEAE) scale. | Within 8 weeks after the initial dose of depatuxizumab mafodotin |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Change From Baseline on the Logarithm of the Minimum Angle of Resolution (LogMAR) Scale | The LogMAR scale measures visual acuity on a continuous scale, with a LogMAR value of 0 equivalent to 20/20 visual acuity. Normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment. The baseline observation is defined as the last non-missing measurement collected prior to the first dose of depatuxizumab mafodotin. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Usc /Id# 164235 | Los Angeles | California | 90033 | United States | ||
| Moffitt Cancer Center /ID# 164234 |
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
All randomized participants
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Steroids | Steroid eye drops: 1 drop each eye, 3 times/day, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days |
| FG001 | Standard Steroids + Vasoconstrictor + Cold Compress |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 28, 2019 | Feb 16, 2021 |
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|
| Vasoconstrictor eye drops | Drug | Solution, eye drop |
|
| Cold compress | Other | Cold compress |
|
| Ophthalmic steroid ointment | Drug | Ointment |
|
| Depatuxizumab mafodotin | Drug | During the Chemoradiation Phase, participants were to receive depatuxizumab mafodotin at 2.0 mg/kg IV infusion over 30 - 40 minutes once every 2 weeks (Day 1 of Weeks 1, 3, and 5 of the 6-week regimen). During the Adjuvant Therapy Phase, participants were to receive depatuxizumab mafodotin at 1.25 mg/kg on Day 1 (± 2 days) and Day 15 (± 2 days) of each 28-day cycle as a 30 - 40 minute infusion for 12 cycles. |
|
|
| Temozolomide | Drug | Temozolomide was to be administered according to the local standard of care. Duration of treatment was to be 6 - 12 cycles in the adjuvant phase and at the discretion of the investigator as supported by local standard of care. |
|
| Radiation | Radiation | Radiation therapy treatment planning and administration was to be performed as per local institutional guidelines. |
|
| Within 8 weeks after the initial dose of depatuxizumab mafodotin |
| Time to Bandage Contact Lens (BCL) Intervention | The time to initiation of bandage contact lenses for those participants who required intervention due to inadequate control of ocular side effects (OSE) was calculated. | Up to 9 months after the first dose of depatuxizumab mafodotin |
| Number of Participants With Depatuxizumab Mafodotin Dose Modifications Due to Ocular Side Effects (OSE) | Dose modifications included depatuxizumab mafodotin withdrawal, interruption, and reductions in dose initiated due to OSEs. | From the first dose of study drug until 49 days after last depatuxizumab mafodotin administration, up to 47 weeks |
| Cumulative Dose of Depatuxizumab Mafodotin Received During Chemoradiation and During Adjuvant Treatment | The cumulative dose of depatuxizumab mafodotin administered was tabulated. | Up to 9 months |
| Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | The corneal epithelial adverse event (CEAE) rating scale is designed to record symptoms associated with corneal epitheliopathy caused by antibody-drug conjugates and to grade the severity of findings. The overall CEAE grade is measured on a scale of 0 to 5, with higher values being more severe, reflecting the impact of corneal abnormalities on visual activities of daily living (ADLs). Additional detailed information is collected for specific domains that are commonly affected, with the following ranges (each in order of increasing severity): ocular discomfort (0 - 4), photophobia (0 - 3), and reading (1 - 3). | Up to 47 weeks |
| Change From Baseline In Logarithm of the Minimum Angle of Resolution (LogMAR) Scale After Bandage Contact Lens (BCL) Intervention | The change on the LogMAR Scale from last assessment prior to BCL intervention to 2 weeks after BCL intervention was calculated. The LogMAR scale measures visual acuity on a continuous scale, with a LogMAR value of 0 equivalent to 20/20 visual acuity. Normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment. | From the last assessment prior to BCL intervention to 2 weeks after BCL intervention |
| Percentage of Participants That Recovered to <3-line Decline From Baseline (≤ +0.3 LogMAR) in Visual Acuity After Bandage Contact Lens (BCL) Intervention | Recovery was defined as return to <3-line decline from baseline (≤ +0.3 LogMAR) in visual acuity after BCL intervention. | From the last assessment prior to BCL intervention to the end of BCL intervention |
| Number of Participants With Depatuxizumab Mafodotin Dose Modifications to Ocular Side Effects After Bandage Contact Lens (BCL) Intervention | Dose modifications included depatuxizumab mafodotin withdrawal, interruption, and reductions in dose initiated due to OSEs after BCL intervention. | From the last assessment prior to BCL intervention to the end of BCL intervention, up to 38 weeks |
| Time to Restart Depatuxizumab Mafodotin if Interrupted Due to Ocular Side Effects After Bandage Contact Lens (BCL) Intervention | The time to restart depatuxizumab mafodotin treatment if it was interrupted due to ocular side effects after BCL Intervention was tabulated. | From the last assessment prior to BCL intervention to the end of BCL intervention |
| Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | The corneal epithelial adverse event (CEAE) rating scale is designed to record symptoms associated with corneal epitheliopathy caused by antibody-drug conjugates and to grade the severity of findings. The overall CEAE grade is measured on a scale of 0 to 5, with higher values being more severe, reflecting the impact of corneal abnormalities on visual activities of daily living (ADLs). Additional detailed information is collected for specific domains that are commonly affected, with the following ranges (each in order of increasing severity): ocular discomfort (0 - 4), photophobia (0 - 3), and reading (1 - 3). | From the last assessment prior to BCL intervention to the end of BCL intervention, up to 38 weeks |
| Time to Ocular Side Effect (OSE) Symptom Resolution After Drug Discontinuation (Reversibility) | The time from discontinuation of depatuxizumab mafodotin to OSE symptom resolution (reversibility) was to be recorded. | From the first dose of study drug until 49 days after last depatuxizumab mafodotin administration, up to 47 weeks |
| Time to Re-initiation of Depatuxizumab Mafodotin After Dose Interruption | The time from dose interruption until re-initiation or permanent discontinuation of depatuxizumab mafodotin was to be recorded. | Up to 9 months |
| Tampa |
| Florida |
| 33612-9416 |
| United States |
| Rush University Medical Center /ID# 171003 | Chicago | Illinois | 60612 | United States |
| Northshore University Health System-Evanston /ID# 164221 | Evanston | Illinois | 60201 | United States |
| CDH-Delnor Health System /ID# 169909 | Warrenville | Illinois | 60555 | United States |
| Columbia University Medical Center /ID# 164220 | New York | New York | 10032-3729 | United States |
| Levine Cancer Ins, Carolina Me /ID# 171271 | Charlotte | North Carolina | 28204 | United States |
| UT Health Science Ctr-Houston /ID# 164223 | Houston | Texas | 77030 | United States |
| Baylor Scott & White Medical Center- Temple /ID# 170792 | Temple | Texas | 76508-0001 | United States |
| Royal North Shore Hospital /ID# 169673 | Saint Leonards | New South Wales | 2065 | Australia |
| Calvary Mater Newcastle /ID# 169672 | Waratah | New South Wales | 2298 | Australia |
| Royal Brisbane and Women's Hospital /ID# 169674 | Herston | Queensland | 4029 | Australia |
| Austin Hospital /ID# 169671 | Heidelberg | Victoria | 3084 | Australia |
| Universitaetsklinik Heidelberg /ID# 169970 | Heidelberg | Baden-Wurttemberg | 69120 | Germany |
| Universitaetsklinikum Leipzig /ID# 169969 | Leipzig | Saxony | 04103 | Germany |
| Klinikum Univ. Regensburg /ID# 169963 | Regensburg | 93042 | Germany |
| Universitatsklinikum Tubingen /ID# 169965 | Tübingen | 72076 | Germany |
| Vrije Universiteit Medisch Centrum /ID# 170152 | Amsterdam | 1081 HV | Netherlands |
| Universitair Medisch Centrum Utrecht /ID# 170149 | Utrecht | 3584 CX | Netherlands |
| Guy's and St Thomas' NHS Found /ID# 207752 | London | London, City of | SE1 9RT | United Kingdom |
| Queen Elizabeth Hospital - BIRMINGHAM /ID# 200657 | Birmingham | B15 2TH | United Kingdom |
| Castle Hill Hospital /ID# 200662 | Cottingham | HU16 5JQ | United Kingdom |
Steroid eye drops: 1 drop each eye, 3 times/day, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Vasoconstrictor Eye Drops: 1 drop each eye 4 - 6 times on day of infusion in total (5 - 10 minutes before infusion; at end of infusion; and 2 - 4 times during the remainder of the infusion day). Continuing 4 - 6 times/day on Day 1 and Day 2 after each depatuxizumab mafodotin infusion; Cold Compress: Starting 5 minutes prior to start of infusion and continuing for 30 minutes past end of infusion, and then use at least 2 hours total/day on Days 1 - 3 with each depatuxizumab mafodotin infusion. The cold compress was to be applied in increments no longer than 30 min (could be shorter if the participant was uncomfortable). |
| FG002 | Enhanced Steroids + Vasoconstrictor + Cold Compress | Enhanced steroid eye drops: 1 drop each eye, 6 times/day, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Ophthalmic Steroid Ointment; applied to each eye once daily before sleep, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Vasoconstrictor Eye Drops: 1 drop each eye 4 - 6 times on day of infusion in total (5 - 10 minutes before infusion; at end of infusion; and 2 - 4 times during the remainder of the infusion day). Continuing 4 - 6 times/day on Day 1 and Day 2 after each depatuxizumab mafodotin infusion; Cold Compress: Starting 5 minutes prior to start of infusion and continuing for 30 minutes past end of infusion, and then use at least 2 hours total/day on Days 1 - 3 with each depatuxizumab mafodotin infusion. Cold compress was to be applied in increments no longer than 30 min (could be shorter if the patient is uncomfortable). |
| FG003 | Untreated Participants | Participants who were randomized to the study but received no doses of depatuxizumab mafodotin or prophylactic eye treatments |
| COMPLETED |
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| NOT COMPLETED |
|
|
Safety population: All randomized participants who received at least 1 dose of depatuxizumab mafodotin
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Standard Steroids | Steroid eye drops: 1 drop each eye, 3 times/day, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days |
| BG001 | Standard Steroids + Vasoconstrictor + Cold Compress | Steroid eye drops: 1 drop each eye, 3 times/day, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Vasoconstrictor Eye Drops: 1 drop each eye 4 - 6 times on day of infusion in total (5 - 10 minutes before infusion; at end of infusion; and 2 - 4 times during the remainder of the infusion day). Continuing 4 - 6 times/day on Day 1 and Day 2 after each depatuxizumab mafodotin infusion; Cold Compress: Starting 5 minutes prior to start of infusion and continuing for 30 minutes past end of infusion, and then use at least 2 hours total/day on Days 1 - 3 with each depatuxizumab mafodotin infusion. The cold compress was to be applied in increments no longer than 30 min (could be shorter if the participant was uncomfortable). |
| BG002 | Enhanced Steroids + Vasoconstrictor + Cold Compress | Enhanced steroid eye drops: 1 drop each eye, 6 times/day, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Ophthalmic Steroid Ointment; applied to each eye once daily before sleep, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Vasoconstrictor Eye Drops: 1 drop each eye 4 - 6 times on day of infusion in total (5 - 10 minutes before infusion; at end of infusion; and 2 - 4 times during the remainder of the infusion day). Continuing 4 - 6 times/day on Day 1 and Day 2 after each depatuxizumab mafodotin infusion; Cold Compress: Starting 5 minutes prior to start of infusion and continuing for 30 minutes past end of infusion, and then use at least 2 hours total/day on Days 1 - 3 with each depatuxizumab mafodotin infusion. Cold compress was to be applied in increments no longer than 30 min (could be shorter if the patient is uncomfortable). |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Race/Ethnicity, Customized | Count of Participants | Participants | No |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Required a Change in Ocular Side Effect (OSE) Management | Inadequate control of ocular side effects (OSE) was defined as either a ≥ 3-line decline from baseline (≥ +0.3 on LogMAR scale) in visual acuity (with baseline correction determined at the screening ophthalmology visit)) or ≥ Grade 3 OSE severity on the Corneal Epithelial Adverse Event (CEAE) scale. | Safety population: all randomized participants who received at least 1 dose of depatuxizumab mafodotin and had at least 1 post-baseline assessment within 8 weeks after the initial dose for either LogMAR or CEAE | Posted | Number | percentage of participants | Within 8 weeks after the initial dose of depatuxizumab mafodotin |
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| Secondary | Maximum Change From Baseline on the Logarithm of the Minimum Angle of Resolution (LogMAR) Scale | The LogMAR scale measures visual acuity on a continuous scale, with a LogMAR value of 0 equivalent to 20/20 visual acuity. Normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment. The baseline observation is defined as the last non-missing measurement collected prior to the first dose of depatuxizumab mafodotin. | Safety population: all randomized participants who received at least 1 dose of depatuxizumab mafodotin and had available data. | Posted | Mean | Standard Deviation | units on a scale | Within 8 weeks after the initial dose of depatuxizumab mafodotin |
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| Secondary | Time to Bandage Contact Lens (BCL) Intervention | The time to initiation of bandage contact lenses for those participants who required intervention due to inadequate control of ocular side effects (OSE) was calculated. | Safety population: all randomized participants who received at least 1 dose of depatuxizumab mafodotin and had available data | Posted | Median | 95% Confidence Interval | months | Up to 9 months after the first dose of depatuxizumab mafodotin |
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| Secondary | Number of Participants With Depatuxizumab Mafodotin Dose Modifications Due to Ocular Side Effects (OSE) | Dose modifications included depatuxizumab mafodotin withdrawal, interruption, and reductions in dose initiated due to OSEs. | Safety population: all randomized participants who received at least 1 dose of depatuxizumab mafodotin and had available data | Posted | Count of Participants | Participants | No | From the first dose of study drug until 49 days after last depatuxizumab mafodotin administration, up to 47 weeks |
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| Secondary | Cumulative Dose of Depatuxizumab Mafodotin Received During Chemoradiation and During Adjuvant Treatment | The cumulative dose of depatuxizumab mafodotin administered was tabulated. | Safety population: all randomized participants who received at least 1 dose of depatuxizumab mafodotin and had available data | Posted | Mean | Standard Deviation | mg/kg | Up to 9 months |
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| Secondary | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | The corneal epithelial adverse event (CEAE) rating scale is designed to record symptoms associated with corneal epitheliopathy caused by antibody-drug conjugates and to grade the severity of findings. The overall CEAE grade is measured on a scale of 0 to 5, with higher values being more severe, reflecting the impact of corneal abnormalities on visual activities of daily living (ADLs). Additional detailed information is collected for specific domains that are commonly affected, with the following ranges (each in order of increasing severity): ocular discomfort (0 - 4), photophobia (0 - 3), and reading (1 - 3). | Safety population: all randomized participants who received at least 1 dose of depatuxizumab mafodotin and had available data | Posted | Count of Participants | Participants | No | Up to 47 weeks |
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| Secondary | Change From Baseline In Logarithm of the Minimum Angle of Resolution (LogMAR) Scale After Bandage Contact Lens (BCL) Intervention | The change on the LogMAR Scale from last assessment prior to BCL intervention to 2 weeks after BCL intervention was calculated. The LogMAR scale measures visual acuity on a continuous scale, with a LogMAR value of 0 equivalent to 20/20 visual acuity. Normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment. | Safety population: all randomized participants who received at least 1 dose of depatuxizumab mafodotin and had available data | Posted | Mean | Standard Deviation | units on a scale | From the last assessment prior to BCL intervention to 2 weeks after BCL intervention |
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| Secondary | Percentage of Participants That Recovered to <3-line Decline From Baseline (≤ +0.3 LogMAR) in Visual Acuity After Bandage Contact Lens (BCL) Intervention | Recovery was defined as return to <3-line decline from baseline (≤ +0.3 LogMAR) in visual acuity after BCL intervention. | Data were not collected for this outcome (due to early termination of the study). | Posted | From the last assessment prior to BCL intervention to the end of BCL intervention |
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| Secondary | Number of Participants With Depatuxizumab Mafodotin Dose Modifications to Ocular Side Effects After Bandage Contact Lens (BCL) Intervention | Dose modifications included depatuxizumab mafodotin withdrawal, interruption, and reductions in dose initiated due to OSEs after BCL intervention. | Safety population: all randomized participants who received at least 1 dose of depatuxizumab mafodotin and had available data | Posted | Number | participants | From the last assessment prior to BCL intervention to the end of BCL intervention, up to 38 weeks |
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| Secondary | Time to Restart Depatuxizumab Mafodotin if Interrupted Due to Ocular Side Effects After Bandage Contact Lens (BCL) Intervention | The time to restart depatuxizumab mafodotin treatment if it was interrupted due to ocular side effects after BCL Intervention was tabulated. | Data were not collected for this outcome (due to early termination of the study). | Posted | From the last assessment prior to BCL intervention to the end of BCL intervention |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | The corneal epithelial adverse event (CEAE) rating scale is designed to record symptoms associated with corneal epitheliopathy caused by antibody-drug conjugates and to grade the severity of findings. The overall CEAE grade is measured on a scale of 0 to 5, with higher values being more severe, reflecting the impact of corneal abnormalities on visual activities of daily living (ADLs). Additional detailed information is collected for specific domains that are commonly affected, with the following ranges (each in order of increasing severity): ocular discomfort (0 - 4), photophobia (0 - 3), and reading (1 - 3). | Safety population: all randomized participants who received at least 1 dose of depatuxizumab mafodotin and had available data | Posted | Count of Participants | Participants | No | From the last assessment prior to BCL intervention to the end of BCL intervention, up to 38 weeks |
| |||||||||||||||||||||||||||||||||||
| Secondary | Time to Ocular Side Effect (OSE) Symptom Resolution After Drug Discontinuation (Reversibility) | The time from discontinuation of depatuxizumab mafodotin to OSE symptom resolution (reversibility) was to be recorded. | Data were not collected for this outcome (due to early termination of the study). | Posted | From the first dose of study drug until 49 days after last depatuxizumab mafodotin administration, up to 47 weeks |
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| Secondary | Time to Re-initiation of Depatuxizumab Mafodotin After Dose Interruption | The time from dose interruption until re-initiation or permanent discontinuation of depatuxizumab mafodotin was to be recorded. | Data were not collected for this outcome (due to early termination of the study). | Posted | Up to 9 months |
|
Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 49 days after last depatuxizumab mafodotin administration, up to 47 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of depatuxizumab mafodotin is administered until 49 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Steroids | Steroid eye drops: 1 drop each eye, 3 times/day, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days | 1 | 14 | 6 | 14 | 14 | 14 |
| EG001 | Standard Steroids + Vasoconstrictor + Cold Compress | Steroid eye drops: 1 drop each eye, 3 times/day, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Vasoconstrictor Eye Drops: 1 drop each eye 4 - 6 times on day of infusion in total (5 - 10 minutes before infusion; at end of infusion; and 2 - 4 times during the remainder of the infusion day). Continuing 4 - 6 times/day on Day 1 and Day 2 after each depatuxizumab mafodotin infusion; Cold Compress: Starting 5 minutes prior to start of infusion and continuing for 30 minutes past end of infusion, and then use at least 2 hours total/day on Days 1 - 3 with each depatuxizumab mafodotin infusion. The cold compress was to be applied in increments no longer than 30 min (could be shorter if the participant was uncomfortable). | 1 | 12 | 4 | 12 | 12 | 12 |
| EG002 | Enhanced Steroids + Vasoconstrictor + Cold Compress | Enhanced steroid eye drops: 1 drop each eye, 6 times/day, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Ophthalmic Steroid Ointment; applied to each eye once daily before sleep, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Vasoconstrictor Eye Drops: 1 drop each eye 4 - 6 times on day of infusion in total (5 - 10 minutes before infusion; at end of infusion; and 2 - 4 times during the remainder of the infusion day). Continuing 4 - 6 times/day on Day 1 and Day 2 after each depatuxizumab mafodotin infusion; Cold Compress: Starting 5 minutes prior to start of infusion and continuing for 30 minutes past end of infusion, and then use at least 2 hours total/day on Days 1 - 3 with each depatuxizumab mafodotin infusion. Cold compress was to be applied in increments no longer than 30 min (could be shorter if the patient is uncomfortable). | 1 | 12 | 4 | 12 | 12 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| ULCERATIVE KERATITIS | Eye disorders | MedDRA 22.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| EYE INFECTION | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| MALIGNANT NEOPLASM PROGRESSION | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| TUMOUR PSEUDOPROGRESSION | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| HEMIPARESIS | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| SEIZURE | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| STATUS EPILEPTICUS | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
| |
| HAEMATOMA | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| LYMPHOPENIA | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| CARDIOMEGALY | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
| |
| TACHYCARDIA | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
| |
| EAR PAIN | Ear and labyrinth disorders | MedDRA 22.1 | Systematic Assessment |
| |
| HYPOACUSIS | Ear and labyrinth disorders | MedDRA 22.1 | Systematic Assessment |
| |
| ACQUIRED EPIBLEPHARON | Eye disorders | MedDRA 22.1 | Systematic Assessment |
| |
| CONJUNCTIVITIS ALLERGIC | Eye disorders | MedDRA 22.1 | Systematic Assessment |
| |
| DIPLOPIA | Eye disorders | MedDRA 22.1 | Systematic Assessment |
| |
| DRY EYE | Eye disorders | MedDRA 22.1 | Systematic Assessment |
| |
| EYELID PTOSIS | Eye disorders | MedDRA 22.1 | Systematic Assessment |
| |
| FOREIGN BODY SENSATION IN EYES | Eye disorders | MedDRA 22.1 | Systematic Assessment |
| |
| VISION BLURRED | Eye disorders | MedDRA 22.1 | Systematic Assessment |
| |
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| ANAL INCONTINENCE | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| DRY MOUTH | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| DUODENAL ULCER | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| DYSPHAGIA | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| GASTRITIS EROSIVE | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| HAEMORRHOIDAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| MOUTH ULCERATION | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| DRUG-INDUCED LIVER INJURY | Hepatobiliary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| HYPERSENSITIVITY | Immune system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| BALANITIS CANDIDA | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| ORAL CANDIDIASIS | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| ORAL HERPES | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| ARTHROPOD BITE | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| CORNEAL ABRASION | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| INCISION SITE PAIN | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| INFUSION RELATED REACTION | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| RADIATION NECROSIS | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| RADIATION SKIN INJURY | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| SKIN ABRASION | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| BLOOD BILIRUBIN ABNORMAL | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| BLOOD CALCIUM INCREASED | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| BLOOD PHOSPHORUS DECREASED | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| CARDIAC MURMUR | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| INTRAOCULAR PRESSURE INCREASED | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| LYMPHOCYTE COUNT DECREASED | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| NEUTROPHIL COUNT DECREASED | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| NEUTROPHIL COUNT INCREASED | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| MALNUTRITION | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| APHASIA | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| APRAXIA | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| BALANCE DISORDER | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| BRAIN OEDEMA | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| CEREBRAL HAEMORRHAGE | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| DYSGEUSIA | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| HEMIPARESIS | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| MEMORY IMPAIRMENT | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| SEIZURE | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| TREMOR | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| VASOGENIC CEREBRAL OEDEMA | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| AGITATION | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| CONFUSIONAL STATE | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| NOCTURIA | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| URINARY INCONTINENCE | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| MENSTRUATION IRREGULAR | Reproductive system and breast disorders | MedDRA 22.1 | Systematic Assessment |
| |
| PROSTATIC OBSTRUCTION | Reproductive system and breast disorders | MedDRA 22.1 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| PLEURITIC PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| PULMONARY OEDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| RHINITIS ALLERGIC | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| DERMATITIS | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| DERMATITIS ACNEIFORM | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| PETECHIAE | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| RASH PRURITIC | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| SCAR PAIN | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 1, 2020 | Feb 16, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
Not provided
Not provided
| ID | Term |
|---|---|
| C000631685 | depatuxizumab mafodotin |
| C000620234 | ABT-414 |
| D000077204 | Temozolomide |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D055585 | Physical Phenomena |
Not provided
Not provided
| Male |
|
| Black or African American |
|
| Asian |
|
|
| OG002 | Enhanced Steroids + Vasoconstrictor + Cold Compress | Enhanced steroid eye drops: 1 drop each eye, 6 times/day, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Ophthalmic Steroid Ointment; applied to each eye once daily before sleep, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Vasoconstrictor Eye Drops: 1 drop each eye 4 - 6 times on day of infusion in total (5 - 10 minutes before infusion; at end of infusion; and 2 - 4 times during the remainder of the infusion day). Continuing 4 - 6 times/day on Day 1 and Day 2 after each depatuxizumab mafodotin infusion; Cold Compress: Starting 5 minutes prior to start of infusion and continuing for 30 minutes past end of infusion, and then use at least 2 hours total/day on Days 1 - 3 with each depatuxizumab mafodotin infusion. Cold compress was to be applied in increments no longer than 30 min (could be shorter if the patient is uncomfortable). |
|
|
| OG002 | Enhanced Steroids + Vasoconstrictor + Cold Compress | Enhanced steroid eye drops: 1 drop each eye, 6 times/day, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Ophthalmic Steroid Ointment; applied to each eye once daily before sleep, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Vasoconstrictor Eye Drops: 1 drop each eye 4 - 6 times on day of infusion in total (5 - 10 minutes before infusion; at end of infusion; and 2 - 4 times during the remainder of the infusion day). Continuing 4 - 6 times/day on Day 1 and Day 2 after each depatuxizumab mafodotin infusion; Cold Compress: Starting 5 minutes prior to start of infusion and continuing for 30 minutes past end of infusion, and then use at least 2 hours total/day on Days 1 - 3 with each depatuxizumab mafodotin infusion. Cold compress was to be applied in increments no longer than 30 min (could be shorter if the patient is uncomfortable). |
|
|
| OG002 | Enhanced Steroids + Vasoconstrictor + Cold Compress | Enhanced steroid eye drops: 1 drop each eye, 6 times/day, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Ophthalmic Steroid Ointment; applied to each eye once daily before sleep, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Vasoconstrictor Eye Drops: 1 drop each eye 4 - 6 times on day of infusion in total (5 - 10 minutes before infusion; at end of infusion; and 2 - 4 times during the remainder of the infusion day). Continuing 4 - 6 times/day on Day 1 and Day 2 after each depatuxizumab mafodotin infusion; Cold Compress: Starting 5 minutes prior to start of infusion and continuing for 30 minutes past end of infusion, and then use at least 2 hours total/day on Days 1 - 3 with each depatuxizumab mafodotin infusion. Cold compress was to be applied in increments no longer than 30 min (could be shorter if the patient is uncomfortable). |
|
|
| OG002 | Enhanced Steroids + Vasoconstrictor + Cold Compress | Enhanced steroid eye drops: 1 drop each eye, 6 times/day, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Ophthalmic Steroid Ointment; applied to each eye once daily before sleep, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Vasoconstrictor Eye Drops: 1 drop each eye 4 - 6 times on day of infusion in total (5 - 10 minutes before infusion; at end of infusion; and 2 - 4 times during the remainder of the infusion day). Continuing 4 - 6 times/day on Day 1 and Day 2 after each depatuxizumab mafodotin infusion; Cold Compress: Starting 5 minutes prior to start of infusion and continuing for 30 minutes past end of infusion, and then use at least 2 hours total/day on Days 1 - 3 with each depatuxizumab mafodotin infusion. Cold compress was to be applied in increments no longer than 30 min (could be shorter if the patient is uncomfortable). |
|
|
| OG002 | Enhanced Steroids + Vasoconstrictor + Cold Compress | Enhanced steroid eye drops: 1 drop each eye, 6 times/day, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Ophthalmic Steroid Ointment; applied to each eye once daily before sleep, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Vasoconstrictor Eye Drops: 1 drop each eye 4 - 6 times on day of infusion in total (5 - 10 minutes before infusion; at end of infusion; and 2 - 4 times during the remainder of the infusion day). Continuing 4 - 6 times/day on Day 1 and Day 2 after each depatuxizumab mafodotin infusion; Cold Compress: Starting 5 minutes prior to start of infusion and continuing for 30 minutes past end of infusion, and then use at least 2 hours total/day on Days 1 - 3 with each depatuxizumab mafodotin infusion. Cold compress was to be applied in increments no longer than 30 min (could be shorter if the patient is uncomfortable). |
|
|
| OG002 | Enhanced Steroids + Vasoconstrictor + Cold Compress | Enhanced steroid eye drops: 1 drop each eye, 6 times/day, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Ophthalmic Steroid Ointment; applied to each eye once daily before sleep, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Vasoconstrictor Eye Drops: 1 drop each eye 4 - 6 times on day of infusion in total (5 - 10 minutes before infusion; at end of infusion; and 2 - 4 times during the remainder of the infusion day). Continuing 4 - 6 times/day on Day 1 and Day 2 after each depatuxizumab mafodotin infusion; Cold Compress: Starting 5 minutes prior to start of infusion and continuing for 30 minutes past end of infusion, and then use at least 2 hours total/day on Days 1 - 3 with each depatuxizumab mafodotin infusion. Cold compress was to be applied in increments no longer than 30 min (could be shorter if the patient is uncomfortable). |
|
|
| OG002 | Enhanced Steroids + Vasoconstrictor + Cold Compress | Enhanced steroid eye drops: 1 drop each eye, 6 times/day, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Ophthalmic Steroid Ointment; applied to each eye once daily before sleep, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Vasoconstrictor Eye Drops: 1 drop each eye 4 - 6 times on day of infusion in total (5 - 10 minutes before infusion; at end of infusion; and 2 - 4 times during the remainder of the infusion day). Continuing 4 - 6 times/day on Day 1 and Day 2 after each depatuxizumab mafodotin infusion; Cold Compress: Starting 5 minutes prior to start of infusion and continuing for 30 minutes past end of infusion, and then use at least 2 hours total/day on Days 1 - 3 with each depatuxizumab mafodotin infusion. Cold compress was to be applied in increments no longer than 30 min (could be shorter if the patient is uncomfortable). |
|
| OG002 | Enhanced Steroids + Vasoconstrictor + Cold Compress | Enhanced steroid eye drops: 1 drop each eye, 6 times/day, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Ophthalmic Steroid Ointment; applied to each eye once daily before sleep, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Vasoconstrictor Eye Drops: 1 drop each eye 4 - 6 times on day of infusion in total (5 - 10 minutes before infusion; at end of infusion; and 2 - 4 times during the remainder of the infusion day). Continuing 4 - 6 times/day on Day 1 and Day 2 after each depatuxizumab mafodotin infusion; Cold Compress: Starting 5 minutes prior to start of infusion and continuing for 30 minutes past end of infusion, and then use at least 2 hours total/day on Days 1 - 3 with each depatuxizumab mafodotin infusion. Cold compress was to be applied in increments no longer than 30 min (could be shorter if the patient is uncomfortable). |
|
|
| OG002 | Enhanced Steroids + Vasoconstrictor + Cold Compress | Enhanced steroid eye drops: 1 drop each eye, 6 times/day, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Ophthalmic Steroid Ointment; applied to each eye once daily before sleep, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Vasoconstrictor Eye Drops: 1 drop each eye 4 - 6 times on day of infusion in total (5 - 10 minutes before infusion; at end of infusion; and 2 - 4 times during the remainder of the infusion day). Continuing 4 - 6 times/day on Day 1 and Day 2 after each depatuxizumab mafodotin infusion; Cold Compress: Starting 5 minutes prior to start of infusion and continuing for 30 minutes past end of infusion, and then use at least 2 hours total/day on Days 1 - 3 with each depatuxizumab mafodotin infusion. Cold compress was to be applied in increments no longer than 30 min (could be shorter if the patient is uncomfortable). |
|
| OG002 | Enhanced Steroids + Vasoconstrictor + Cold Compress | Enhanced steroid eye drops: 1 drop each eye, 6 times/day, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Ophthalmic Steroid Ointment; applied to each eye once daily before sleep, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Vasoconstrictor Eye Drops: 1 drop each eye 4 - 6 times on day of infusion in total (5 - 10 minutes before infusion; at end of infusion; and 2 - 4 times during the remainder of the infusion day). Continuing 4 - 6 times/day on Day 1 and Day 2 after each depatuxizumab mafodotin infusion; Cold Compress: Starting 5 minutes prior to start of infusion and continuing for 30 minutes past end of infusion, and then use at least 2 hours total/day on Days 1 - 3 with each depatuxizumab mafodotin infusion. Cold compress was to be applied in increments no longer than 30 min (could be shorter if the patient is uncomfortable). |
|
|
| OG002 | Enhanced Steroids + Vasoconstrictor + Cold Compress | Enhanced steroid eye drops: 1 drop each eye, 6 times/day, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Ophthalmic Steroid Ointment; applied to each eye once daily before sleep, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Vasoconstrictor Eye Drops: 1 drop each eye 4 - 6 times on day of infusion in total (5 - 10 minutes before infusion; at end of infusion; and 2 - 4 times during the remainder of the infusion day). Continuing 4 - 6 times/day on Day 1 and Day 2 after each depatuxizumab mafodotin infusion; Cold Compress: Starting 5 minutes prior to start of infusion and continuing for 30 minutes past end of infusion, and then use at least 2 hours total/day on Days 1 - 3 with each depatuxizumab mafodotin infusion. Cold compress was to be applied in increments no longer than 30 min (could be shorter if the patient is uncomfortable). |
|
| OG002 |
| Enhanced Steroids + Vasoconstrictor + Cold Compress |
Enhanced steroid eye drops: 1 drop each eye, 6 times/day, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Ophthalmic Steroid Ointment; applied to each eye once daily before sleep, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Vasoconstrictor Eye Drops: 1 drop each eye 4 - 6 times on day of infusion in total (5 - 10 minutes before infusion; at end of infusion; and 2 - 4 times during the remainder of the infusion day). Continuing 4 - 6 times/day on Day 1 and Day 2 after each depatuxizumab mafodotin infusion; Cold Compress: Starting 5 minutes prior to start of infusion and continuing for 30 minutes past end of infusion, and then use at least 2 hours total/day on Days 1 - 3 with each depatuxizumab mafodotin infusion. Cold compress was to be applied in increments no longer than 30 min (could be shorter if the patient is uncomfortable). |
|