UNITE Study: Understanding New Interventions With GBM ThErapy
Sponsor
AbbVie (Industry)
Overall Status
Terminated
CT.gov ID
NCT03419403
Collaborator
(none)
40
22
3
19.1
1.8
0.1
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase 3b Study for Management of Ocular Side Effects in Subjects With EGFR-amplified Glioblastoma Receiving Depatuxizumab Mafodotin (ABT-414)
Actual Study Start Date
:
Jul 30, 2018
Actual Primary Completion Date
:
Sep 5, 2019
Actual Study Completion Date
:
Mar 3, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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 |
Drug: Steroid eye drops
Solution, eye drop
Drug: Depatuxizumab mafodotin
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.
Other Names:
Drug: Temozolomide
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.
|
| Experimental: 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). |
Drug: Steroid eye drops
Solution, eye drop
Drug: Vasoconstrictor eye drops
Solution, eye drop
Other: Cold compress
Cold compress
Drug: Depatuxizumab mafodotin
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.
Other Names:
Drug: Temozolomide
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.
|
| Experimental: 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). |
Drug: Steroid eye drops
Solution, eye drop
Drug: Vasoconstrictor eye drops
Solution, eye drop
Other: Cold compress
Cold compress
Drug: Ophthalmic steroid ointment
Ointment
Drug: Depatuxizumab mafodotin
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.
Other Names:
Drug: Temozolomide
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.
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants Who Required a Change in Ocular Side Effect (OSE) Management [Within 8 weeks after the initial dose of depatuxizumab mafodotin]
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.
Secondary Outcome Measures
- Maximum Change From Baseline on the Logarithm of the Minimum Angle of Resolution (LogMAR) Scale [Within 8 weeks after the initial dose of depatuxizumab mafodotin]
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.
- Time to Bandage Contact Lens (BCL) Intervention [Up to 9 months after the first dose of depatuxizumab mafodotin]
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.
- Number of Participants With Depatuxizumab Mafodotin Dose Modifications Due to Ocular Side Effects (OSE) [From the first dose of study drug until 49 days after last depatuxizumab mafodotin administration, up to 47 weeks]
Dose modifications included depatuxizumab mafodotin withdrawal, interruption, and reductions in dose initiated due to OSEs.
- Cumulative Dose of Depatuxizumab Mafodotin Received During Chemoradiation and During Adjuvant Treatment [Up to 9 months]
The cumulative dose of depatuxizumab mafodotin administered was tabulated.
- Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit [Up to 47 weeks]
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).
- Change From Baseline In Logarithm of the Minimum Angle of Resolution (LogMAR) Scale After Bandage Contact Lens (BCL) Intervention [From the last assessment prior to BCL intervention to 2 weeks after 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.
- Percentage of Participants That Recovered to <3-line Decline From Baseline (≤ +0.3 LogMAR) in Visual Acuity After Bandage Contact Lens (BCL) Intervention [From the last assessment prior to BCL intervention to the end of BCL intervention]
Recovery was defined as return to <3-line decline from baseline (≤ +0.3 LogMAR) in visual acuity after BCL intervention.
- Number of Participants With Depatuxizumab Mafodotin Dose Modifications to Ocular Side Effects After Bandage Contact Lens (BCL) Intervention [From the last assessment prior to BCL intervention to the end of BCL intervention, up to 38 weeks]
Dose modifications included depatuxizumab mafodotin withdrawal, interruption, and reductions in dose initiated due to OSEs after BCL intervention.
- Time to Restart Depatuxizumab Mafodotin if Interrupted Due to Ocular Side Effects After Bandage Contact Lens (BCL) Intervention [From the last assessment prior to BCL intervention to the end of BCL intervention]
The time to restart depatuxizumab mafodotin treatment if it was interrupted due to ocular side effects after BCL Intervention was tabulated.
- Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention [From the last assessment prior to BCL intervention to the end of BCL intervention, up to 38 weeks]
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).
- Time to Ocular Side Effect (OSE) Symptom Resolution After Drug Discontinuation (Reversibility) [From the first dose of study drug until 49 days after last depatuxizumab mafodotin administration, up to 47 weeks]
The time from discontinuation of depatuxizumab mafodotin to OSE symptom resolution (reversibility) was to be recorded.
- Time to Re-initiation of Depatuxizumab Mafodotin After Dose Interruption [Up to 9 months]
The time from dose interruption until re-initiation or permanent discontinuation of depatuxizumab mafodotin was to be recorded.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Newly diagnosed glioblastoma (GBM) histologically proven, World Health Organization (WHO) grade IV GBM or WHO grade IV gliosarcoma
-
Tumors must demonstrate epidermal growth factor receptor (EGFR) amplification
-
Tumors must be supratentorial in location
-
Participant must have recovered from the effects of surgery, postoperative infection, and other complications; has no significant post-operative hemorrhage
-
Participant has a Karnofsky performance status (KPS) of 70 or higher
-
Participant has adequate bone marrow, renal, and hepatic function
-
Electrocardiogram without evidence of acute cardiac ischemia ≤ 21 days prior to randomization
-
Participant has a life expectancy of ≥ 3 months
Exclusion Criteria:
-
Participant has received prior chemotherapy or radiotherapy for cancer of the head and neck region
-
Participant has received prior treatment with Gliadel wafers or any other intratumoral or intracavitary treatment
-
Participant has hypersensitivity to any component of temozolomide or dacarbazine
-
Participant has received anti-cancer therapy (including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational therapy) within 5 years of Study Day 1
-
Participant has clinically significant uncontrolled condition(s) as described in the protocol
-
Participant has any medical condition which in the opinion of the investigator places the participant at an unacceptably high risk for toxicities
-
Participant has had another active malignancy within the past 3 years except for any cancer considered cured or non-melanoma carcinoma of the skin
-
Participant has a history of herpetic keratitis
-
Participant is not suitable for receiving ocular steroids with conditions as described in the protocol
-
Participant has had laser-assisted in situ keratomileusis (LASIK) procedure within the last 1 year or cataract surgery within the last 3 months
-
Participant has a visual condition that compromises the ability to accurately measure visual acuity or assess visual activities of daily living (vADLs)
-
Participant has hepatitis B virus or hepatitis C virus infection
-
Participant not receiving treatment with highly active antiretroviral therapy (HAART) when positive for human immunodeficiency virus (HIV)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Usc /Id# 164235 | Los Angeles | California | United States | 90033 |
| 2 | Moffitt Cancer Center /ID# 164234 | Tampa | Florida | United States | 33612-9416 |
| 3 | Rush University Medical Center /ID# 171003 | Chicago | Illinois | United States | 60612 |
| 4 | Northshore University Health System-Evanston /ID# 164221 | Evanston | Illinois | United States | 60201 |
| 5 | CDH-Delnor Health System /ID# 169909 | Warrenville | Illinois | United States | 60555 |
| 6 | Columbia University Medical Center /ID# 164220 | New York | New York | United States | 10032-3729 |
| 7 | Levine Cancer Ins, Carolina Me /ID# 171271 | Charlotte | North Carolina | United States | 28204 |
| 8 | UT Health Science Ctr-Houston /ID# 164223 | Houston | Texas | United States | 77030 |
| 9 | Baylor Scott & White Medical Center- Temple /ID# 170792 | Temple | Texas | United States | 76508-0001 |
| 10 | Royal North Shore Hospital /ID# 169673 | Saint Leonards | New South Wales | Australia | 2065 |
| 11 | Calvary Mater Newcastle /ID# 169672 | Waratah | New South Wales | Australia | 2298 |
| 12 | Royal Brisbane and Women's Hospital /ID# 169674 | Herston | Queensland | Australia | 4029 |
| 13 | Austin Hospital /ID# 169671 | Heidelberg | Victoria | Australia | 3084 |
| 14 | Universitaetsklinik Heidelberg /ID# 169970 | Heidelberg | Baden-Wuerttemberg | Germany | 69120 |
| 15 | Universitaetsklinikum Leipzig /ID# 169969 | Leipzig | Sachsen | Germany | 04103 |
| 16 | Klinikum Univ. Regensburg /ID# 169963 | Regensburg | Germany | 93042 | |
| 17 | Universitatsklinikum Tubingen /ID# 169965 | Tuebingen | Germany | 72076 | |
| 18 | Vrije Universiteit Medisch Centrum /ID# 170152 | Amsterdam | Netherlands | 1081 HV | |
| 19 | Universitair Medisch Centrum Utrecht /ID# 170149 | Utrecht | Netherlands | 3584 CX | |
| 20 | Guy's and St Thomas' NHS Found /ID# 207752 | London | London, City Of | United Kingdom | SE1 9RT |
| 21 | Queen Elizabeth Hospital - BIRMINGHAM /ID# 200657 | Birmingham | United Kingdom | B15 2TH | |
| 22 | Castle Hill Hospital /ID# 200662 | Cottingham | United Kingdom | HU16 5JQ |
Sponsors and Collaborators
- AbbVie
Investigators
- Study Director: AbbVie Inc., AbbVie
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
AbbVie
ClinicalTrials.gov Identifier:
NCT03419403
Other Study ID Numbers:
- M16-534
- 2017-003171-64
First Posted:
Feb 5, 2018
Last Update Posted:
Apr 14, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by AbbVie
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | All randomized participants |
| Arm/Group Title | Standard Steroids | Standard Steroids + Vasoconstrictor + Cold Compress | Enhanced Steroids + Vasoconstrictor + Cold Compress | Untreated Participants |
|---|---|---|---|---|
| Arm/Group Description | 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 | 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 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). | Participants who were randomized to the study but received no doses of depatuxizumab mafodotin or prophylactic eye treatments |
| Period Title: Overall Study | ||||
| STARTED | 14 | 12 | 12 | 2 |
| COMPLETED | 2 | 3 | 0 | 0 |
| NOT COMPLETED | 12 | 9 | 12 | 2 |
Baseline Characteristics
| Arm/Group Title | Standard Steroids | Standard Steroids + Vasoconstrictor + Cold Compress | Enhanced Steroids + Vasoconstrictor + Cold Compress | Total |
|---|---|---|---|---|
| Arm/Group Description | 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 | 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 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). | Total of all reporting groups |
| Overall Participants | 14 | 12 | 12 | 38 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
47.6
(9.85)
|
55.2
(10.53)
|
57.3
(8.69)
|
53.1
(10.39)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
3
21.4%
|
4
33.3%
|
1
8.3%
|
8
21.1%
|
| Male |
11
78.6%
|
8
66.7%
|
11
91.7%
|
30
78.9%
|
| Race/Ethnicity, Customized (Count of Participants) | ||||
| White |
12
85.7%
|
12
100%
|
12
100%
|
36
94.7%
|
| Black or African American |
1
7.1%
|
0
0%
|
0
0%
|
1
2.6%
|
| Asian |
1
7.1%
|
0
0%
|
0
0%
|
1
2.6%
|
Outcome Measures
| Title | Percentage of Participants Who Required a Change in Ocular Side Effect (OSE) Management |
|---|---|
| Description | 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. |
| Time Frame | Within 8 weeks after the initial dose of depatuxizumab mafodotin |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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 |
| Arm/Group Title | Standard Steroids | Standard Steroids + Vasoconstrictor + Cold Compress | Enhanced Steroids + Vasoconstrictor + Cold Compress |
|---|---|---|---|
| Arm/Group Description | 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 | 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 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). |
| Measure Participants | 14 | 12 | 12 |
| Bilateral vision |
50.0
357.1%
|
27.3
227.5%
|
41.7
347.5%
|
| Vision in worst eye |
64.3
459.3%
|
72.7
605.8%
|
50.0
416.7%
|
| Title | Maximum Change From Baseline on the Logarithm of the Minimum Angle of Resolution (LogMAR) Scale |
|---|---|
| Description | 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. |
| Time Frame | Within 8 weeks after the initial dose of depatuxizumab mafodotin |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population: all randomized participants who received at least 1 dose of depatuxizumab mafodotin and had available data. |
| Arm/Group Title | Standard Steroids | Standard Steroids + Vasoconstrictor + Cold Compress | Enhanced Steroids + Vasoconstrictor + Cold Compress |
|---|---|---|---|
| Arm/Group Description | 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 | 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 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). |
| Measure Participants | 12 | 10 | 9 |
| Bilateral vision |
0.353
(0.1888)
|
0.402
(0.1985)
|
0.272
(0.3888)
|
| Vision in worst eye |
0.482
(0.2028)
|
0.528
(0.3073)
|
0.430
(0.5120)
|
| Title | Time to Bandage Contact Lens (BCL) Intervention |
|---|---|
| Description | 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. |
| Time Frame | Up to 9 months after the first dose of depatuxizumab mafodotin |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population: all randomized participants who received at least 1 dose of depatuxizumab mafodotin and had available data |
| Arm/Group Title | Standard Steroids | Standard Steroids + Vasoconstrictor + Cold Compress | Enhanced Steroids + Vasoconstrictor + Cold Compress |
|---|---|---|---|
| Arm/Group Description | 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 | 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 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). |
| Measure Participants | 14 | 12 | 12 |
| Median (95% Confidence Interval) [months] |
NA
|
3.6
|
2.1
|
| Title | Number of Participants With Depatuxizumab Mafodotin Dose Modifications Due to Ocular Side Effects (OSE) |
|---|---|
| Description | Dose modifications included depatuxizumab mafodotin withdrawal, interruption, and reductions in dose initiated due to OSEs. |
| Time Frame | From the first dose of study drug until 49 days after last depatuxizumab mafodotin administration, up to 47 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population: all randomized participants who received at least 1 dose of depatuxizumab mafodotin and had available data |
| Arm/Group Title | Standard Steroids | Standard Steroids + Vasoconstrictor + Cold Compress | Enhanced Steroids + Vasoconstrictor + Cold Compress |
|---|---|---|---|
| Arm/Group Description | 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 | 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 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). |
| Measure Participants | 14 | 12 | 12 |
| Count of Participants [Participants] |
2
14.3%
|
3
25%
|
2
16.7%
|
| Title | Cumulative Dose of Depatuxizumab Mafodotin Received During Chemoradiation and During Adjuvant Treatment |
|---|---|
| Description | The cumulative dose of depatuxizumab mafodotin administered was tabulated. |
| Time Frame | Up to 9 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population: all randomized participants who received at least 1 dose of depatuxizumab mafodotin and had available data |
| Arm/Group Title | Standard Steroids | Standard Steroids + Vasoconstrictor + Cold Compress | Enhanced Steroids + Vasoconstrictor + Cold Compress |
|---|---|---|---|
| Arm/Group Description | 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 | 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 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). |
| Measure Participants | 14 | 12 | 12 |
| Mean (Standard Deviation) [mg/kg] |
8.5
(5.86)
|
10.5
(7.35)
|
7.0
(3.67)
|
| Title | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit |
|---|---|
| Description | 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). |
| Time Frame | Up to 47 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population: all randomized participants who received at least 1 dose of depatuxizumab mafodotin and had available data |
| Arm/Group Title | Standard Steroids | Standard Steroids + Vasoconstrictor + Cold Compress | Enhanced Steroids + Vasoconstrictor + Cold Compress |
|---|---|---|---|
| Arm/Group Description | 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 | 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 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). |
| Measure Participants | 14 | 12 | 12 |
| Week 1: Grade 0 |
10
71.4%
|
8
66.7%
|
5
41.7%
|
| Week 1: Grade 1 |
1
7.1%
|
3
25%
|
1
8.3%
|
| Week 3: Grade 0 |
4
28.6%
|
5
41.7%
|
7
58.3%
|
| Week 3: Grade 1 |
10
71.4%
|
6
50%
|
3
25%
|
| Week 3: Grade 2 |
0
0%
|
0
0%
|
1
8.3%
|
| Week 5: Grade 0 |
1
7.1%
|
0
0%
|
2
16.7%
|
| Week 5: Grade 1 |
7
50%
|
5
41.7%
|
6
50%
|
| Week 5: Grade 2 |
1
7.1%
|
3
25%
|
2
16.7%
|
| Week 5: Grade 3 |
4
28.6%
|
2
16.7%
|
2
16.7%
|
| Week 7: Grade 0 |
0
0%
|
0
0%
|
2
16.7%
|
| Week 7: Grade 1 |
3
21.4%
|
4
33.3%
|
0
0%
|
| Week 7: Grade 2 |
4
28.6%
|
6
50%
|
5
41.7%
|
| Week 7: Grade 3 |
2
14.3%
|
0
0%
|
2
16.7%
|
| Week 9: Grade 0 |
1
7.1%
|
0
0%
|
1
8.3%
|
| Week 9: Grade 1 |
1
7.1%
|
2
16.7%
|
0
0%
|
| Week 9: Grade 2 |
3
21.4%
|
5
41.7%
|
4
33.3%
|
| Week 9: Grade 3 |
2
14.3%
|
0
0%
|
1
8.3%
|
| Week 11: Grade 0 |
0
0%
|
0
0%
|
1
8.3%
|
| Week 11: Grade 1 |
2
14.3%
|
1
8.3%
|
0
0%
|
| Week 11: Grade 2 |
2
14.3%
|
0
0%
|
3
25%
|
| Week 11: Grade 3 |
1
7.1%
|
0
0%
|
1
8.3%
|
| Week 11: Grade 4 |
1
7.1%
|
0
0%
|
0
0%
|
| Week 13: Grade 1 |
1
7.1%
|
0
0%
|
1
8.3%
|
| Adj Week 1: Grade 0 |
0
0%
|
1
8.3%
|
0
0%
|
| Adj Week 1: Grade 1 |
1
7.1%
|
3
25%
|
2
16.7%
|
| Adj Week 1: Grade 2 |
3
21.4%
|
2
16.7%
|
2
16.7%
|
| Adj Week 1: Grade 3 |
1
7.1%
|
0
0%
|
0
0%
|
| Adj Week 5: Grade 0 |
0
0%
|
2
16.7%
|
2
16.7%
|
| Adj Week 5: Grade 1 |
1
7.1%
|
3
25%
|
0
0%
|
| Adj Week 5: Grade 2 |
4
28.6%
|
0
0%
|
1
8.3%
|
| Adj Week 5: Grade 3 |
1
7.1%
|
1
8.3%
|
0
0%
|
| Adj Week 9: Grade 0 |
0
0%
|
1
8.3%
|
0
0%
|
| Adj Week 9: Grade 1 |
0
0%
|
2
16.7%
|
1
8.3%
|
| Adj Week 9: Grade 2 |
2
14.3%
|
2
16.7%
|
2
16.7%
|
| Adj Week 9: Grade 3 |
1
7.1%
|
1
8.3%
|
0
0%
|
| Adj Week 13: Grade 0 |
0
0%
|
1
8.3%
|
0
0%
|
| Adj Week 13: Grade 1 |
0
0%
|
2
16.7%
|
0
0%
|
| Adj Week 13: Grade 2 |
2
14.3%
|
2
16.7%
|
2
16.7%
|
| Adj Week 13: Grade 3 |
1
7.1%
|
0
0%
|
0
0%
|
| Adj Week 17: Grade 0 |
0
0%
|
0
0%
|
1
8.3%
|
| Adj Week 17: Grade 1 |
0
0%
|
1
8.3%
|
0
0%
|
| Adj Week 17: Grade 2 |
2
14.3%
|
3
25%
|
0
0%
|
| Adj Week 21: Grade 1 |
0
0%
|
0
0%
|
1
8.3%
|
| Adj Week 21: Grade 2 |
2
14.3%
|
3
25%
|
0
0%
|
| Adj Week 25: Grade 1 |
0
0%
|
2
16.7%
|
0
0%
|
| Adj Week 25: Grade 2 |
1
7.1%
|
1
8.3%
|
0
0%
|
| Adj Week 29: Grade 2 |
1
7.1%
|
0
0%
|
0
0%
|
| Adj Week 29: Grade 4 |
0
0%
|
1
8.3%
|
0
0%
|
| Title | Change From Baseline In Logarithm of the Minimum Angle of Resolution (LogMAR) Scale After Bandage Contact Lens (BCL) Intervention |
|---|---|
| Description | 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. |
| Time Frame | From the last assessment prior to BCL intervention to 2 weeks after BCL intervention |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population: all randomized participants who received at least 1 dose of depatuxizumab mafodotin and had available data |
| Arm/Group Title | Standard Steroids | Standard Steroids + Vasoconstrictor + Cold Compress | Enhanced Steroids + Vasoconstrictor + Cold Compress |
|---|---|---|---|
| Arm/Group Description | 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 | 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 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). |
| Measure Participants | 4 | 2 | 3 |
| Within 8 weeks of first dose: Bilateral vision |
0.325
(0.1248)
|
0.13
(0.099)
|
0.54
(0.1442)
|
| Within 8 weeks of first dose: Vision in worst eye |
0.435
(0.0574)
|
0.52
(0.3111)
|
0.867
(0.2914)
|
| Within 8 weeks of first adjuvant dose: Bilateral vision |
-0.1
|
0.41
(0.2404)
|
|
| Within 8 weeks of first adjuvant dose: Vision in worst eye |
-0.1
|
0.33
(0.0141)
|
| Title | Percentage of Participants That Recovered to <3-line Decline From Baseline (≤ +0.3 LogMAR) in Visual Acuity After Bandage Contact Lens (BCL) Intervention |
|---|---|
| Description | Recovery was defined as return to <3-line decline from baseline (≤ +0.3 LogMAR) in visual acuity after BCL intervention. |
| Time Frame | From the last assessment prior to BCL intervention to the end of BCL intervention |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data were not collected for this outcome (due to early termination of the study). |
| Arm/Group Title | Standard Steroids | Standard Steroids + Vasoconstrictor + Cold Compress | Enhanced Steroids + Vasoconstrictor + Cold Compress |
|---|---|---|---|
| Arm/Group Description | 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 | 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 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). |
| Measure Participants | 0 | 0 | 0 |
| Title | Number of Participants With Depatuxizumab Mafodotin Dose Modifications to Ocular Side Effects After Bandage Contact Lens (BCL) Intervention |
|---|---|
| Description | Dose modifications included depatuxizumab mafodotin withdrawal, interruption, and reductions in dose initiated due to OSEs after BCL intervention. |
| Time Frame | From the last assessment prior to BCL intervention to the end of BCL intervention, up to 38 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population: all randomized participants who received at least 1 dose of depatuxizumab mafodotin and had available data |
| Arm/Group Title | Standard Steroids | Standard Steroids + Vasoconstrictor + Cold Compress | Enhanced Steroids + Vasoconstrictor + Cold Compress |
|---|---|---|---|
| Arm/Group Description | 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 | 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 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). |
| Measure Participants | 14 | 12 | 12 |
| Number [participants] |
2
14.3%
|
1
8.3%
|
0
0%
|
| Title | Time to Restart Depatuxizumab Mafodotin if Interrupted Due to Ocular Side Effects After Bandage Contact Lens (BCL) Intervention |
|---|---|
| Description | The time to restart depatuxizumab mafodotin treatment if it was interrupted due to ocular side effects after BCL Intervention was tabulated. |
| Time Frame | From the last assessment prior to BCL intervention to the end of BCL intervention |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data were not collected for this outcome (due to early termination of the study). |
| Arm/Group Title | Standard Steroids | Standard Steroids + Vasoconstrictor + Cold Compress | Enhanced Steroids + Vasoconstrictor + Cold Compress |
|---|---|---|---|
| Arm/Group Description | 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 | 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 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). |
| Measure Participants | 0 | 0 | 0 |
| Title | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention |
|---|---|
| Description | 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). |
| Time Frame | From the last assessment prior to BCL intervention to the end of BCL intervention, up to 38 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population: all randomized participants who received at least 1 dose of depatuxizumab mafodotin and had available data |
| Arm/Group Title | Standard Steroids | Standard Steroids + Vasoconstrictor + Cold Compress | Enhanced Steroids + Vasoconstrictor + Cold Compress |
|---|---|---|---|
| Arm/Group Description | 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 | 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 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). |
| Measure Participants | 7 | 4 | 4 |
| Week 5: Grade 1 |
2
14.3%
|
0
0%
|
0
0%
|
| Week 7: Grade 2 |
1
7.1%
|
1
8.3%
|
0
0%
|
| Week 9: Grade 2 |
1
7.1%
|
1
8.3%
|
1
8.3%
|
| Week 11: Grade 2 |
0
0%
|
0
0%
|
2
16.7%
|
| Week 11: Grade 3 |
1
7.1%
|
0
0%
|
0
0%
|
| Week 13: Grade 1 |
1
7.1%
|
0
0%
|
0
0%
|
| Adj Week 1: Grade 1 |
0
0%
|
0
0%
|
1
8.3%
|
| Adj Week 1: Grade 2 |
0
0%
|
0
0%
|
1
8.3%
|
| Adj Week 5: Grade 0 |
0
0%
|
1
8.3%
|
1
8.3%
|
| Adj Week 5: Grade 1 |
0
0%
|
1
8.3%
|
0
0%
|
| Adj Week 5: Grade 2 |
1
7.1%
|
0
0%
|
1
8.3%
|
| Adj Week 5: Grade 3 |
1
7.1%
|
0
0%
|
0
0%
|
| Adj Week 9: Grade 0 |
0
0%
|
1
8.3%
|
0
0%
|
| Adj Week 9: Grade 1 |
0
0%
|
0
0%
|
1
8.3%
|
| Adj Week 9: Grade 2 |
0
0%
|
0
0%
|
1
8.3%
|
| Adj Week 9: Grade 3 |
1
7.1%
|
0
0%
|
0
0%
|
| Adj Week 13: Grade 0 |
0
0%
|
2
16.7%
|
0
0%
|
| Adj Week 13: Grade 1 |
0
0%
|
1
8.3%
|
0
0%
|
| Adj Week 13: Grade 2 |
1
7.1%
|
0
0%
|
1
8.3%
|
| Adj Week 13: Grade 3 |
1
7.1%
|
0
0%
|
0
0%
|
| Adj Week 17: Grade 1 |
0
0%
|
1
8.3%
|
0
0%
|
| Adj Week 17: Grade 2 |
1
7.1%
|
1
8.3%
|
0
0%
|
| Adj Week 21: Grade 2 |
2
14.3%
|
1
8.3%
|
0
0%
|
| Adj Week 25: Grade 1 |
0
0%
|
1
8.3%
|
0
0%
|
| Adj Week 25: Grade 2 |
1
7.1%
|
0
0%
|
0
0%
|
| Adj Week 29: Grade 2 |
1
7.1%
|
0
0%
|
0
0%
|
| Title | Time to Ocular Side Effect (OSE) Symptom Resolution After Drug Discontinuation (Reversibility) |
|---|---|
| Description | The time from discontinuation of depatuxizumab mafodotin to OSE symptom resolution (reversibility) was to be recorded. |
| Time Frame | From the first dose of study drug until 49 days after last depatuxizumab mafodotin administration, up to 47 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data were not collected for this outcome (due to early termination of the study). |
| Arm/Group Title | Standard Steroids | Standard Steroids + Vasoconstrictor + Cold Compress | Enhanced Steroids + Vasoconstrictor + Cold Compress |
|---|---|---|---|
| Arm/Group Description | 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 | 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 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). |
| Measure Participants | 0 | 0 | 0 |
| Title | Time to Re-initiation of Depatuxizumab Mafodotin After Dose Interruption |
|---|---|
| Description | The time from dose interruption until re-initiation or permanent discontinuation of depatuxizumab mafodotin was to be recorded. |
| Time Frame | Up to 9 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data were not collected for this outcome (due to early termination of the study). |
| Arm/Group Title | Standard Steroids | Standard Steroids + Vasoconstrictor + Cold Compress | Enhanced Steroids + Vasoconstrictor + Cold Compress |
|---|---|---|---|
| Arm/Group Description | 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 | 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 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). |
| Measure Participants | 0 | 0 | 0 |
Adverse Events
| Time Frame | 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. | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | 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. | |||||
| Arm/Group Title | Standard Steroids | Standard Steroids + Vasoconstrictor + Cold Compress | Enhanced Steroids + Vasoconstrictor + Cold Compress | |||
| Arm/Group Description | 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 | 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 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). | |||
All Cause Mortality |
||||||
| Standard Steroids | Standard Steroids + Vasoconstrictor + Cold Compress | Enhanced Steroids + Vasoconstrictor + Cold Compress | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/14 (7.1%) | 1/12 (8.3%) | 1/12 (8.3%) | |||
Serious Adverse Events |
||||||
| Standard Steroids | Standard Steroids + Vasoconstrictor + Cold Compress | Enhanced Steroids + Vasoconstrictor + Cold Compress | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 6/14 (42.9%) | 4/12 (33.3%) | 4/12 (33.3%) | |||
| Blood and lymphatic system disorders | ||||||
| FEBRILE NEUTROPENIA | 0/14 (0%) | 0 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
| THROMBOCYTOPENIA | 1/14 (7.1%) | 1 | 1/12 (8.3%) | 1 | 1/12 (8.3%) | 1 |
| Eye disorders | ||||||
| ULCERATIVE KERATITIS | 0/14 (0%) | 0 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
| Gastrointestinal disorders | ||||||
| VOMITING | 1/14 (7.1%) | 1 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| General disorders | ||||||
| PYREXIA | 1/14 (7.1%) | 1 | 0/12 (0%) | 0 | 1/12 (8.3%) | 1 |
| Infections and infestations | ||||||
| CELLULITIS | 1/14 (7.1%) | 1 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| EYE INFECTION | 0/14 (0%) | 0 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
| LOWER RESPIRATORY TRACT INFECTION | 1/14 (7.1%) | 1 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| PNEUMONIA | 0/14 (0%) | 0 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
| Investigations | ||||||
| ALANINE AMINOTRANSFERASE INCREASED | 1/14 (7.1%) | 1 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| MALIGNANT NEOPLASM PROGRESSION | 1/14 (7.1%) | 1 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| TUMOUR PSEUDOPROGRESSION | 0/14 (0%) | 0 | 0/12 (0%) | 0 | 1/12 (8.3%) | 1 |
| Nervous system disorders | ||||||
| HEADACHE | 0/14 (0%) | 0 | 0/12 (0%) | 0 | 1/12 (8.3%) | 1 |
| HEMIPARESIS | 1/14 (7.1%) | 1 | 1/12 (8.3%) | 1 | 1/12 (8.3%) | 1 |
| SEIZURE | 1/14 (7.1%) | 1 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
| STATUS EPILEPTICUS | 0/14 (0%) | 0 | 0/12 (0%) | 0 | 1/12 (8.3%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| PULMONARY EMBOLISM | 1/14 (7.1%) | 1 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| Vascular disorders | ||||||
| DEEP VEIN THROMBOSIS | 1/14 (7.1%) | 1 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| HAEMATOMA | 1/14 (7.1%) | 1 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||
| Standard Steroids | Standard Steroids + Vasoconstrictor + Cold Compress | Enhanced Steroids + Vasoconstrictor + Cold Compress | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 14/14 (100%) | 12/12 (100%) | 12/12 (100%) | |||
| Blood and lymphatic system disorders | ||||||
| ANAEMIA | 1/14 (7.1%) | 1 | 2/12 (16.7%) | 2 | 1/12 (8.3%) | 1 |
| LEUKOPENIA | 0/14 (0%) | 0 | 0/12 (0%) | 0 | 1/12 (8.3%) | 2 |
| LYMPHOPENIA | 0/14 (0%) | 0 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
| NEUTROPENIA | 1/14 (7.1%) | 1 | 1/12 (8.3%) | 2 | 1/12 (8.3%) | 2 |
| THROMBOCYTOPENIA | 3/14 (21.4%) | 4 | 5/12 (41.7%) | 7 | 3/12 (25%) | 7 |
| Cardiac disorders | ||||||
| CARDIOMEGALY | 0/14 (0%) | 0 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
| TACHYCARDIA | 0/14 (0%) | 0 | 1/12 (8.3%) | 1 | 1/12 (8.3%) | 1 |
| Ear and labyrinth disorders | ||||||
| EAR PAIN | 1/14 (7.1%) | 1 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| HYPOACUSIS | 0/14 (0%) | 0 | 1/12 (8.3%) | 2 | 0/12 (0%) | 0 |
| Eye disorders | ||||||
| ACQUIRED EPIBLEPHARON | 0/14 (0%) | 0 | 0/12 (0%) | 0 | 1/12 (8.3%) | 1 |
| CONJUNCTIVITIS ALLERGIC | 0/14 (0%) | 0 | 0/12 (0%) | 0 | 1/12 (8.3%) | 1 |
| DIPLOPIA | 0/14 (0%) | 0 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
| DRY EYE | 0/14 (0%) | 0 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
| EYELID PTOSIS | 0/14 (0%) | 0 | 0/12 (0%) | 0 | 1/12 (8.3%) | 1 |
| FOREIGN BODY SENSATION IN EYES | 0/14 (0%) | 0 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
| VISION BLURRED | 0/14 (0%) | 0 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
| Gastrointestinal disorders | ||||||
| ABDOMINAL DISTENSION | 1/14 (7.1%) | 1 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| ANAL INCONTINENCE | 0/14 (0%) | 0 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
| CONSTIPATION | 5/14 (35.7%) | 5 | 4/12 (33.3%) | 4 | 2/12 (16.7%) | 2 |
| DIARRHOEA | 1/14 (7.1%) | 1 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
| DRY MOUTH | 0/14 (0%) | 0 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
| DUODENAL ULCER | 0/14 (0%) | 0 | 0/12 (0%) | 0 | 1/12 (8.3%) | 1 |
| DYSPHAGIA | 1/14 (7.1%) | 1 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| GASTRITIS EROSIVE | 0/14 (0%) | 0 | 0/12 (0%) | 0 | 1/12 (8.3%) | 1 |
| HAEMORRHOIDAL HAEMORRHAGE | 0/14 (0%) | 0 | 2/12 (16.7%) | 2 | 0/12 (0%) | 0 |
| HAEMORRHOIDS | 0/14 (0%) | 0 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
| MOUTH ULCERATION | 0/14 (0%) | 0 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
| NAUSEA | 6/14 (42.9%) | 7 | 6/12 (50%) | 7 | 3/12 (25%) | 3 |
| STOMATITIS | 0/14 (0%) | 0 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
| VOMITING | 5/14 (35.7%) | 5 | 1/12 (8.3%) | 1 | 1/12 (8.3%) | 1 |
| General disorders | ||||||
| ASTHENIA | 1/14 (7.1%) | 1 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
| CHEST PAIN | 0/14 (0%) | 0 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
| FATIGUE | 6/14 (42.9%) | 10 | 9/12 (75%) | 10 | 7/12 (58.3%) | 8 |
| INFLUENZA LIKE ILLNESS | 0/14 (0%) | 0 | 0/12 (0%) | 0 | 1/12 (8.3%) | 1 |
| OEDEMA PERIPHERAL | 0/14 (0%) | 0 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
| PYREXIA | 1/14 (7.1%) | 2 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| Hepatobiliary disorders | ||||||
| DRUG-INDUCED LIVER INJURY | 0/14 (0%) | 0 | 2/12 (16.7%) | 3 | 0/12 (0%) | 0 |
| Immune system disorders | ||||||
| HYPERSENSITIVITY | 0/14 (0%) | 0 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
| Infections and infestations | ||||||
| BALANITIS CANDIDA | 1/14 (7.1%) | 1 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| NASOPHARYNGITIS | 1/14 (7.1%) | 1 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| ORAL CANDIDIASIS | 1/14 (7.1%) | 1 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| ORAL HERPES | 1/14 (7.1%) | 1 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| SINUSITIS | 1/14 (7.1%) | 1 | 0/12 (0%) | 0 | 1/12 (8.3%) | 1 |
| UPPER RESPIRATORY TRACT INFECTION | 0/14 (0%) | 0 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
| URINARY TRACT INFECTION | 0/14 (0%) | 0 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||
| ARTHROPOD BITE | 0/14 (0%) | 0 | 0/12 (0%) | 0 | 1/12 (8.3%) | 1 |
| CORNEAL ABRASION | 1/14 (7.1%) | 2 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| FALL | 2/14 (14.3%) | 3 | 0/12 (0%) | 0 | 1/12 (8.3%) | 1 |
| INCISION SITE PAIN | 0/14 (0%) | 0 | 0/12 (0%) | 0 | 1/12 (8.3%) | 1 |
| INFUSION RELATED REACTION | 1/14 (7.1%) | 1 | 0/12 (0%) | 0 | 1/12 (8.3%) | 1 |
| RADIATION NECROSIS | 0/14 (0%) | 0 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
| RADIATION SKIN INJURY | 2/14 (14.3%) | 2 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
| SKIN ABRASION | 1/14 (7.1%) | 1 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| Investigations | ||||||
| ALANINE AMINOTRANSFERASE INCREASED | 2/14 (14.3%) | 2 | 5/12 (41.7%) | 7 | 3/12 (25%) | 4 |
| ASPARTATE AMINOTRANSFERASE INCREASED | 4/14 (28.6%) | 4 | 2/12 (16.7%) | 2 | 2/12 (16.7%) | 3 |
| BLOOD BILIRUBIN ABNORMAL | 1/14 (7.1%) | 1 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| BLOOD CALCIUM INCREASED | 1/14 (7.1%) | 1 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| BLOOD CREATININE INCREASED | 1/14 (7.1%) | 1 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| BLOOD PHOSPHORUS DECREASED | 0/14 (0%) | 0 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
| CARDIAC MURMUR | 0/14 (0%) | 0 | 0/12 (0%) | 0 | 1/12 (8.3%) | 1 |
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | 0/14 (0%) | 0 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
| INTRAOCULAR PRESSURE INCREASED | 1/14 (7.1%) | 1 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| LYMPHOCYTE COUNT DECREASED | 1/14 (7.1%) | 1 | 0/12 (0%) | 0 | 3/12 (25%) | 7 |
| NEUTROPHIL COUNT DECREASED | 0/14 (0%) | 0 | 0/12 (0%) | 0 | 1/12 (8.3%) | 1 |
| NEUTROPHIL COUNT INCREASED | 1/14 (7.1%) | 1 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| WEIGHT DECREASED | 1/14 (7.1%) | 2 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| WHITE BLOOD CELL COUNT DECREASED | 1/14 (7.1%) | 2 | 0/12 (0%) | 0 | 1/12 (8.3%) | 1 |
| Metabolism and nutrition disorders | ||||||
| DECREASED APPETITE | 3/14 (21.4%) | 4 | 3/12 (25%) | 5 | 3/12 (25%) | 3 |
| DEHYDRATION | 0/14 (0%) | 0 | 2/12 (16.7%) | 2 | 0/12 (0%) | 0 |
| HYPERGLYCAEMIA | 0/14 (0%) | 0 | 0/12 (0%) | 0 | 1/12 (8.3%) | 1 |
| HYPOKALAEMIA | 0/14 (0%) | 0 | 1/12 (8.3%) | 1 | 1/12 (8.3%) | 1 |
| HYPONATRAEMIA | 1/14 (7.1%) | 1 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| MALNUTRITION | 0/14 (0%) | 0 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||
| ARTHRALGIA | 1/14 (7.1%) | 1 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| BACK PAIN | 0/14 (0%) | 0 | 1/12 (8.3%) | 1 | 1/12 (8.3%) | 1 |
| MUSCULAR WEAKNESS | 2/14 (14.3%) | 5 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| MUSCULOSKELETAL CHEST PAIN | 1/14 (7.1%) | 1 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| NECK PAIN | 1/14 (7.1%) | 1 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| Nervous system disorders | ||||||
| APHASIA | 1/14 (7.1%) | 1 | 0/12 (0%) | 0 | 1/12 (8.3%) | 1 |
| APRAXIA | 1/14 (7.1%) | 1 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| BALANCE DISORDER | 0/14 (0%) | 0 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
| BRAIN OEDEMA | 1/14 (7.1%) | 1 | 1/12 (8.3%) | 1 | 2/12 (16.7%) | 2 |
| CEREBRAL HAEMORRHAGE | 0/14 (0%) | 0 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
| DIZZINESS | 1/14 (7.1%) | 1 | 1/12 (8.3%) | 2 | 0/12 (0%) | 0 |
| DYSGEUSIA | 0/14 (0%) | 0 | 1/12 (8.3%) | 3 | 1/12 (8.3%) | 1 |
| HEADACHE | 5/14 (35.7%) | 5 | 3/12 (25%) | 3 | 4/12 (33.3%) | 5 |
| HEMIPARESIS | 0/14 (0%) | 0 | 0/12 (0%) | 0 | 2/12 (16.7%) | 2 |
| MEMORY IMPAIRMENT | 1/14 (7.1%) | 1 | 1/12 (8.3%) | 1 | 1/12 (8.3%) | 1 |
| SEIZURE | 1/14 (7.1%) | 1 | 1/12 (8.3%) | 1 | 2/12 (16.7%) | 3 |
| SYNCOPE | 1/14 (7.1%) | 1 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
| TREMOR | 1/14 (7.1%) | 1 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| VASOGENIC CEREBRAL OEDEMA | 1/14 (7.1%) | 1 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| Psychiatric disorders | ||||||
| AGITATION | 0/14 (0%) | 0 | 0/12 (0%) | 0 | 2/12 (16.7%) | 2 |
| ANXIETY | 0/14 (0%) | 0 | 2/12 (16.7%) | 3 | 1/12 (8.3%) | 1 |
| CONFUSIONAL STATE | 0/14 (0%) | 0 | 1/12 (8.3%) | 2 | 0/12 (0%) | 0 |
| DEPRESSION | 1/14 (7.1%) | 1 | 1/12 (8.3%) | 1 | 1/12 (8.3%) | 1 |
| INSOMNIA | 1/14 (7.1%) | 1 | 1/12 (8.3%) | 1 | 1/12 (8.3%) | 1 |
| Renal and urinary disorders | ||||||
| NOCTURIA | 0/14 (0%) | 0 | 0/12 (0%) | 0 | 1/12 (8.3%) | 1 |
| URINARY INCONTINENCE | 0/14 (0%) | 0 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
| Reproductive system and breast disorders | ||||||
| MENSTRUATION IRREGULAR | 1/14 (7.1%) | 1 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| PROSTATIC OBSTRUCTION | 0/14 (0%) | 0 | 0/12 (0%) | 0 | 1/12 (8.3%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| COUGH | 0/14 (0%) | 0 | 2/12 (16.7%) | 4 | 0/12 (0%) | 0 |
| DYSPNOEA EXERTIONAL | 0/14 (0%) | 0 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
| EPISTAXIS | 1/14 (7.1%) | 1 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| OROPHARYNGEAL PAIN | 0/14 (0%) | 0 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
| PLEURITIC PAIN | 0/14 (0%) | 0 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
| PULMONARY OEDEMA | 0/14 (0%) | 0 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
| RHINITIS ALLERGIC | 1/14 (7.1%) | 1 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||
| ALOPECIA | 2/14 (14.3%) | 2 | 2/12 (16.7%) | 2 | 5/12 (41.7%) | 7 |
| DERMATITIS | 0/14 (0%) | 0 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
| DERMATITIS ACNEIFORM | 1/14 (7.1%) | 1 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| DRY SKIN | 1/14 (7.1%) | 1 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| ERYTHEMA | 0/14 (0%) | 0 | 1/12 (8.3%) | 1 | 2/12 (16.7%) | 2 |
| PETECHIAE | 0/14 (0%) | 0 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
| RASH | 3/14 (21.4%) | 4 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
| RASH MACULO-PAPULAR | 1/14 (7.1%) | 1 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| RASH PRURITIC | 0/14 (0%) | 0 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
| SCAR PAIN | 0/14 (0%) | 0 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
| Vascular disorders | ||||||
| DEEP VEIN THROMBOSIS | 0/14 (0%) | 0 | 1/12 (8.3%) | 1 | 1/12 (8.3%) | 1 |
| HYPOTENSION | 0/14 (0%) | 0 | 1/12 (8.3%) | 1 | 1/12 (8.3%) | 1 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Global Medical Services |
|---|---|
| Organization | AbbVie |
| Phone | 800-633-9110 |
| abbvieclinicaltrials@abbvie.com |
Responsible Party:
AbbVie
ClinicalTrials.gov Identifier:
NCT03419403
Other Study ID Numbers:
- M16-534
- 2017-003171-64
First Posted:
Feb 5, 2018
Last Update Posted:
Apr 14, 2021
Last Verified:
Mar 1, 2021