First-in-Human Study to Evaluate the Safety, Tolerability... | NCT01609556 | Trialant
NCT01609556
Sponsor
ImmunoGen, Inc.
Status
Completed
Last Update Posted
Feb 17, 2021Actual
Enrollment
206Actual
Phase
Phase 1
Conditions
Tumors
Interventions
Mirvetuximab soravtansine
Countries
United States
Canada
Protocol Section
Identification Module
NCT ID
NCT01609556
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
IMGN853-0401
Secondary IDs
Not provided
Brief Title
First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Mirvetuximab Soravtansine in Adults With Ovarian Cancer and Other Folate Receptor 1 (FOLR1)-Positive Solid Tumors
Official Title
A Phase 1, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IMGN853 in Adults With Ovarian Cancer and Other FOLR1-Positive Solid Tumors
Acronym
IMGN853-0401
Organization
ImmunoGen, Inc.INDUSTRY
Status Module
Record Verification Date
Jan 2021
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jun 28, 2012Actual
Primary Completion Date
Mar 19, 2018Actual
Completion Date
Mar 19, 2018Actual
First Submitted Date
May 30, 2012
First Submission Date that Met QC Criteria
May 31, 2012
First Posted Date
Jun 1, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 1, 2019
Results First Submitted that Met QC Criteria
Jan 27, 2021
Results First Posted Date
Feb 17, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jan 27, 2021
Last Update Posted Date
Feb 17, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
ImmunoGen, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to test mirvetuximab soravtansine (IMGN853) in participants with ovarian cancer and other FOLR-1 positive tumors.
Detailed Description
The study consists of a dose-escalation phase that will evaluate 2 dosing schedules (Schedule A and Schedule B) of mirvetuximab soravtansine and up to 5 dose-expansion groups at the maximum tolerated dose (MTD). The first 4 escalation cohorts will be single participant cohorts. Subsequent escalation cohorts will use a standard 3+3 design, with each cohort consisting of 3 or 4 to 6 participants. Data were collected and analysed for the escalation and expansion groups by dose schedule and not by individual dose.
Conditions Module
Conditions
Tumors
Keywords
FOLR-1 solid tumors
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
206Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Dose Escalation: Schedule A (Mirvetuximab Soravtansine Q3W)
Experimental
Participants will receive mirvetuximab soravtansine intravenous (IV) infusion on Day 1 of every 21-day (every 3 weeks [Q3W]) cycle. Dose escalation for this group schedule will start at 0.15 milligrams per kilogram (mg/kg) and proceed through 7.0 mg/kg. Doses calculated initially based on participant's total body weight (TBW); then from protocol amendment 5 onwards, calculated based on adjusted ideal body weight (AIBW). Participants will continue to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever comes first, or until the sponsor terminate the study.
Drug: Mirvetuximab soravtansine
Dose Escalation: Schedule B (Mirvetuximab Soravtansine Weekly)
Experimental
Participants will receive mirvetuximab soravtansine IV infusion on Days 1, 8, and 15 of every 28-day cycle. Dose escalation for this group schedule will start at 1.1 mg/kg (calculated based on AIBW) and proceed through 2.5 mg/kg. Participants will continue to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever comes first, or until the sponsor terminate the study.
Participants with epithelial ovarian cancer (EOC) will receive mirvetuximab soravtansine 6.0 mg/kg (maximum tolerated dose [MTD]) IV infusion on Day 1 of every 21-day (Q3W) cycle (calculated based on AIBW). Participants will continue to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever comes first, or until the sponsor terminated the study.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Mirvetuximab soravtansine
Drug
Mirvetuximab soravtansine IV infusion will be administered as per dose and schedule specified in the respective arms.
Dose Escalation: Schedule A (Mirvetuximab Soravtansine Q3W)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Dose-Escalation Phase: Maximum Tolerated Dose (MTD) of Mirvetuximab Soravtansine
MTD was defined as the highest dose at which 1 or fewer among 6 participants or less than or equal to (<=) 33 percent (%) experienced a dose-limiting toxicity (DLT) (calculated based on adjusted ideal body weight [AIBW]). AIBW was calculated as ideal body weight (IBW) + 0.4 * (actual weight - IBW), where IBW for men was 0.9 * height in centimeters (cm) - 88 and IBW for women was 0.9 * height in cm - 92. DLT was defined as a treatment-emergent adverse event (TEAE) or abnormal laboratory value related to study treatment (that is, assessed as unrelated to disease, intercurrent illness, or concomitant medications), including those TEAEs and abnormal laboratory values that resulted in a failure to meet the criteria for re-treatment.
Cycle 1 (21 days)
Dose-Escalation Phase: Recommended Phase 2 Dose (RP2D) of Mirvetuximab Soravtansine
RP2D was determined by MTD. MTD was defined as the highest dose at which 1 or fewer among 6 participants or <=33% experienced a DLT. DLT was defined as a TEAE or abnormal laboratory value related to study treatment (that is, assessed as unrelated to disease, intercurrent illness, or concomitant medications), including those TEAEs and abnormal laboratory values that resulted in a failure to meet the criteria for re-treatment. Available clinical data indicated that the MTD defined for the Q3W schedule was equal to the RP2D.
Cycle 1 (21 days)
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With TEAEs
An adverse event (AE) was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to study drug. Severity was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03 on following scale: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening, Grade 5=death. Serious AEs include death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as any AE that emerged on or after the first dose, and within 28 days of the last dose.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria
Participants with advanced solid tumor that is refractory to standard treatment, for which no standard treatment is available, or the participant refuses standard therapy.
Participants must be willing to provide an archival tumor tissue block or slides for biomarker analysis.
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
Time from prior therapy:
Systemic anti-neoplastic therapy: five half-lives or four weeks, whichever is shorter (6 weeks for prior nitrosoureas or mitomycin C).
Radiotherapy: wide-field radiotherapy (for example, greater than [>] 30 percent [%] of marrow-bearing bones) completed at least four weeks, or focal radiation completed at least two weeks, prior to starting study drug.
Participants must have recovered or stabilized from all therapy-related toxicities.
Major surgery (not including placement of vascular access device or tumor biopsies) must be completed four weeks prior to Day 1. Participants must have recovered or stabilized from the side effects prior to study treatment.
Participants must have adequate hematologic, liver and kidney function.
Participants with central nervous system (CNS) disease involvement are eligible if they have had brain metastases resected or have received radiation therapy ending at least 4 weeks prior to study day 1 and they meet all of the following criteria: Residual neurological symptoms less than or equal to (<=) Grade 1; No dexamethasone requirement; and Follow-up magnetic resonance imaging (MRI) shows no progression of treated lesions and no new lesions appearing.
Participants must be willing and able to sign the informed consent form, and to adhere to the study visit schedule and other protocol requirements.
Women of childbearing potential and men must agree to use effective contraceptive methods while on study and for at least twelve weeks after the last dose of study drug.
Women of childbearing potential must have a negative pregnancy test prior to the first dose of study treatment.
Exclusion Criteria
Grade >1 neuropathy.
Any active or chronic corneal disorder, including, but not limited to the following: Sjogren's syndrome, Fuch's corneal dystrophy (requiring treatment), history of corneal transplantation, active herpetic keratitis, and also active ocular conditions requiring ongoing treatment/monitoring such as wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, presence of papilledema, acquired monocular vision.
Serious concurrent illness, including, but not limited to the following:
Clinically relevant active infection including known active hepatitis B or C, Human Immunodeficiency Virus (HIV) infection, varicella-zoster virus (shingles) or cytomegalovirus infection or any other known concurrent infectious disease, requiring IV antibiotics within 2 weeks of study enrollment.
Significant cardiac disease such as recent myocardial infarction (<=6 months prior to Day 1), unstable angina pectoris, uncontrolled congestive heart failure (New York Heart Association >class II), uncontrolled hypertension (greater than or equal to [>=] Common Terminology Criteria for Adverse Events Version 4.03 [CTCAE v4.03] Grade 3), uncontrolled cardiac arrhythmias, severe aortic stenosis, or >=Grade 3 cardiac toxicity following prior chemotherapy.
History of multiple sclerosis or other demyelinating disease, Eaton-Lambert syndrome (para-neoplastic syndrome), history of hemorrhagic or ischemic stroke within the last six months, or alcoholic liver disease.
Previous clinical diagnosis of treatment-related pneumonitis.
Any other concomitant anti-cancer treatment such as immunotherapy, biotherapy, radiotherapy, chemotherapy, investigative therapy, or high-dose steroids; however, low dose steroids and Luteinizing Hormone Releasing Hormone (LHRH) at doses that have been stable for >=14 days are permitted for participants with prostate cancer.
Known hypersensitivity to previous monoclonal antibody therapy or maytansinoids.
Prior history of solid tumor malignancy within the last 3 years except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, in situ prostate cancer (participants must have shown no evidence of active disease for 2 years prior to enrollment).
Concomitant administration of folate-containing vitamins.
Participants who have received prior allogeneic or autologous bone marrow transplants.
Women of childbearing potential who are pregnant or breast feeding.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Not provided
Locations
Facility
Status
City
State
ZIP
Country
Contacts
University of Kansas Medical Center Research Institute
Fairway
Kansas
66205
United States
Massachusetts General Hospital
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Dose expansion Cohort 4 was planned to enroll relapsed/refractory non-small cell lung cancer (NSCLC) adenocarcinoma or bronchoalveolar carcinoma (BAC) but no participants were enrolled due to a company decision to focus on endometrial and ovarian carcinoma for the initial investigation.
Recruitment Details
A total of 206 participants were enrolled in this study, of whom 69 participants (44 to receive Schedule A and 25 to receive Schedule B treatment) were entered in dose-escalation phase and 137 participants (113 with epithelial ovarian cancer [EOC] and 24 with endometrial cancer [EC]) were entered in dose-expansion phase. Doses calculated initially based on participant's total body weight (TBW); then from protocol amendment 5 onwards, calculated based on adjusted ideal body weight (AIBW).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W)
Participants received mirvetuximab soravtansine 0.15 milligrams (mg)/kilogram (kg) intravenous (IV) infusion on Day 1 of every 21-day (every 3 weeks [Q3W]) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with endometrial cancer (EC) will receive mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle (calculated based on AIBW). Participants will continue to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever comes first, or until the sponsor terminate the study.
Drug: Mirvetuximab soravtansine
Dose Escalation: Schedule B (Mirvetuximab Soravtansine Weekly)
From first dose of study drug up to 28 days after last dose of study drug (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)
Number of Participants With Shift From Baseline Grade <=2 in Clinical Laboratory Parameters to Grade 3 or Grade 4 on Study
Laboratory parameters included serum chemistry (alanine aminotransferase [ALT]/serum glutamic pyruvic transaminase [SGPT], aspartate aminotransferase [AST]/serum glutamic oxaloacetic transaminase [SGOT], albumin, alkaline phosphatase, bilirubin, calcium, creatinine, glucose, magnesium, phosphorous, potassium, sodium), hematology (hemoglobin, lymphocytes, neutrophils, platelets, white blood cells) and coagulation (international normalized ratio [INR], partial thromboplastin time [PTT]). Clinically significant laboratory values were defined as per NCI CTCAE v.03 Grade 3 or higher. A grading (severity) scale was provided with grades ranging from 0 (none), 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening or disabling), to 5 (death). Only participants who shifted from a baseline value of Grade <=2 to a post-baseline Grade 3/4 on-treatment, are reported.
From first dose of study drug up to 28 days after last dose of study drug (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)
Number of Participants With Clinically Significant Abnormalities in Physical Examination Findings and Vital Signs
Physical examination included assessments of general appearance, skin, head (eyes, ears, nose, and throat), neck, lungs, heart, abdomen, back, lymph nodes, extremities, and neurological system. Vital signs included assessment of blood pressure, pulse rate, respiratory rate and body temperature.
From first dose of study drug up to 28 days after last dose of study drug (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG)
Standard ECGs were performed in triplicate at 2- to 5-minute intervals during the study. A single ECG was performed at the end of treatment visit and as clinically indicated.
Baseline up to end of treatment (EOT) (up to maximum 124 weeks)
Number of Participants With Treatment-Emergent Ocular AEs
Ocular AEs included keratopathy and blurred vision. An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to study drug. TEAEs were defined as any AE that emerged on or after the first dose, and within 28 days of the last dose.
From first dose of study drug up to 28 days after last dose of study drug (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)
Maximum Observed Plasma Concentration (Cmax) of Mirvetuximab Soravtansine and Total M9346A Antibody at RP2D
Pharmacokinetic (PK) parameters were calculated using standard non-compartmental methods. PK analysis of mirvetuximab soravtansine and total M9346A antibody is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.
Cycle 1, 3: Day 1 (pre-infusion; within 10 minutes [min] of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion)
Cmax of Free DM4 and S-Methyl DM4 at RP2D
PK parameters were calculated using standard non-compartmental methods. PK analysis of free N2'-[4-[(3-carboxypropyl)dithio]-4-methyl-1-oxo-2-sulfopentyl]-N2'-deacetylmaytansine (DM4) and S-methyl DM4 is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.
Cycle 1, 3: Day 1 (pre-infusion; within 10 min of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion)
Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) of Mirvetuximab Soravtansine and Total M9346A Antibody at RP2D
PK parameters were calculated using standard non-compartmental methods. PK analysis of mirvetuximab soravtansine and total M9346A antibody is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.
Cycle 1, 3: Day 1 (pre-infusion; within 10 min of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion)
AUC0-inf of Free DM4 and S-Methyl DM4 at RP2D
PK parameters were calculated using standard non-compartmental methods. PK analysis of free DM4 and S-methyl DM4 is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.
Cycle 1, 3: Day 1 (pre-infusion; within 10 min of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion)
Area Under the Plasma Concentration-Versus Time Curve From Time of Dose Until Tlast (AUClast) of Mirvetuximab Soravtansine and Total M9346A Antibody at RP2D
PK parameters were calculated using standard non-compartmental methods. PK analysis of mirvetuximab soravtansine and total M9346A antibody is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.
Cycle 1, 3: Day 1 (pre-infusion; within 10 min of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion)
AUClast of Free DM4 and S-Methyl DM4 at RP2D
PK parameters were calculated using standard non-compartmental methods. PK analysis of free DM4 and S-methyl DM4 is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.
Cycle 1, 3: Day 1 (pre-infusion; within 10 min of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion)
Terminal Half-Life (t1/2) of Mirvetuximab Soravtansine,Total M9346A Antibody, DM4, and S-Methyl DM4 at RP2D
PK parameters were calculated using standard non-compartmental methods. PK analysis of mirvetuximab soravtansine, total M9346A antibody, DM4, and S-methyl DM4 is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.
Cycle 1, 3: Day 1 (pre-infusion; within 10 min of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion)
Clearance (CL) of Mirvetuximab Soravtansine and Total M9346A Antibody at RP2D
PK parameters were calculated using standard non-compartmental methods. PK analysis of mirvetuximab soravtansine and total M9346A antibody is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.
Cycle 1, 3: Day 1 (pre-infusion; within 10 min of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion)
CL of DM4 and S-Methyl DM4 at RP2D
PK parameters were calculated using standard non-compartmental methods. PK analysis of DM4 and S-methyl DM4 is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.
Cycle 1, 3: Day 1 (pre-infusion; within 10 min of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion)
Time to Reach Maximum Observed Concentration (Tmax) of Mirvetuximab Soravtansine, Free DM4, S-Methyl DM4, and Total M9346A Antibody at RP2D
PK parameters were calculated using standard non-compartmental methods. PK analysis of mirvetuximab soravtansine, free DM4, S-methyl DM4, and total M9346A antibody is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.
Cycle 1, 3: Day 1 (pre-infusion; within 10 min of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion)
Volume of Distribution at Steady State (Vss) of Mirvetuximab Soravtansine Free DM4, S-Methyl DM4, and Total M9346A Antibody at RP2D
PK parameters were calculated using standard non-compartmental methods. PK analysis of mirvetuximab soravtansine, free DM4, S-methyl DM4, and total M9346A antibody is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.
Cycle 1, 3: Day 1 (pre-infusion; within 10 min of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion)
Objective Response Rate (ORR): Percentage of Participants With Objective Response as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
ORR was defined as percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). CR: Disappearance of all target or non-target lesions. All pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm). PR: At least 30 percent (%) decrease in the sum of the longest diameters (SoD) of target lesions, taking as reference the baseline SoD.
From first dose of study drug until first BOR of CR or PR (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)
Duration of Response (DOR) as Assessed by RECIST v1.1
DOR was defined as the time from the date of the first response (CR or PR), whichever was recorded first, until the date of progressive disease (PD). PD: At least a 20% increase in the SoD of target lesion, taken as reference the smallest (nadir) SoD since and including baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase. DOR was only defined for participants who had a BOR of CR or PR using the method of Kaplan-Meier.
From the date of first response (CR or PR) until the date of PD (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)
Progression-Free Survival (PFS) as Assessed by RECIST v1.1
PFS was defined as the time from initiation of study drug until PD or death whichever occurred first, estimated using the Kaplan-Meier method. PD: At least a 20% increase in the SoD of target lesion, taken as reference the smallest (nadir) SoD since and including baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of non-target lesions and appearance of new lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.
From first dose of study drug until PD or death whichever occurred first (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)
Time to Progression (TTP) as Assessed by RECIST v1.1
TTP was defined as the time from initiation of study drug until PD, estimated using the method of Kaplan-Meier. PD: At least a 20% increase in the SoD of target lesion, taken as reference the smallest (nadir) SoD since and including baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of non-target lesions and appearance of new lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.
From first dose of study drug until PD (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)
Number of Participants With Anti-Drug Antibodies (ADA)
During the conduct of the study, a single immunogenicity assay was developed to concurrently detect human antibodies against all components of mirvetuximab soravtansine, including the humanized anti-FOLR1 antibody, the cleavable disulfide linker, and the cytotoxic maytansinoid, DM4. Therefore, immunogenicity results were reported as ADA titers, and did not distinguish between human anti-drug or anti-human titers.
Baseline up to follow-up visit (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)
Number of Participants With Gynecologic Cancer Intergroup (GCIG) CA-125 Criteria Clinical Responses
CA-125 response was defined as at least 50% reduction in CA-125 levels from baseline. The date of response corresponded to the date when the CA 125 level was first reduced by 50%.
From first dose of study drug until CA-125 response (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)
Boston
Massachusetts
02062
United States
Dana Farber Cancer Institute
Boston
Massachusetts
02115
United States
Barbara Ann Karmanos Cancer Institute
Detroit
Michigan
48201
United States
Memorial Sloan Kettering Cancer Center
New York
New York
10065
United States
Ohio State University
Columbus
Ohio
43210
United States
University of Oklahoma Stephenson Cancer Center
Oklahoma City
Oklahoma
73104
United States
Fox Chase Cancer Center
Philadelphia
Pennsylvania
19111
United States
Sarah Cannon Research Institute
Nashville
Tennessee
37203
United States
CTRC at the University of Texas Health Science Center
San Antonio
Texas
78229
United States
Princess Margaret Hospital
Toronto
Ontario
M5G 2M9
Canada
McGill University Health Centre
Montreal
Quebec
H4A3J1
Canada
FG001
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W)
Participants received mirvetuximab soravtansine 0.5 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
FG002
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 1.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
FG003
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
FG004
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W)
Participants received mirvetuximab soravtansine 3.3 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
FG005
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 5.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
FG006
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 6.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
FG007
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 7.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
FG008
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly)
Participants received mirvetuximab soravtansine 1.1 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
FG009
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly)
Participants received mirvetuximab soravtansine 1.8 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
FG010
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly)
Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
FG011
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly)
Participants received mirvetuximab soravtansine 2.5 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with EOC, primary peritoneal cancer, or fallopian tube cancer resistant to platinum-based therapy received mirvetuximab soravtansine 6.0 mg/kg (maximum tolerated dose [MTD]) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with folate receptor 1 (FOLR1)-positive uterine cancer (that was advanced or recurrent and had received at least 1 platinum-based regimen, and no more than 5 prior systemic treatment regimens for EC) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with biopsy-accessible relapsed or refractory ovarian cancer, primary peritoneal cancer, or fallopian tube cancer received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with EOC primary peritoneal cancer or fallopian tube cancer (that had relapsed following platinum-based therapy, excluding those participants with primary platinum refractory disease or low grade or clear cell ovarian cancer) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
FG0002 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG0049 subjects
FG00518 subjects
FG0067 subjects
FG0075 subjects
FG0085 subjects
FG0094 subjects
FG0109 subjects
FG0117 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
Received at Least 1 Dose of Study Drug
FG0002 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG0049 subjects
FG00518 subjects
FG0067 subjects
FG0075 subjects
FG0085 subjects
FG0094 subjects
FG0109 subjects
FG0117 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
NOT COMPLETED
FG0002 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG0049 subjects
FG00518 subjects
FG0067 subjects
FG0075 subjects
FG0085 subjects
FG0094 subjects
FG0109 subjects
FG0117 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0081 subjects
FG0090 subjects
FG0101 subjects
FG0111 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
Disease Progression
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG004
Clinical Progression
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Began New Anticancer Therapy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Investigator Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Death
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Dose Expansion: Maximum 124 Weeks
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG01246 subjects
FG01324 subjects
FG01427 subjects
FG01540 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Safety population included all participants who were enrolled and received at least 1 dose of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W)
Participants received mirvetuximab soravtansine 0.15 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
BG001
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W)
Participants received mirvetuximab soravtansine 0.5 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
BG002
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 1.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
BG003
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
BG004
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W)
Participants received mirvetuximab soravtansine 3.3 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
BG005
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 5.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
BG006
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 6.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
BG007
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 7.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
BG008
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly)
Participants received mirvetuximab soravtansine 1.1 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
BG009
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly)
Participants received mirvetuximab soravtansine 1.8 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
BG010
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly)
Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
BG011
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly)
Participants received mirvetuximab soravtansine 2.5 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with EOC, primary peritoneal cancer, or fallopian tube cancer resistant to platinum-based therapy received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with FOLR1-positive uterine cancer (that was advanced or recurrent and had received at least 1 platinum-based regimen, and no more than 5 prior systemic treatment regimens for EC) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with biopsy-accessible relapsed or refractory ovarian cancer, primary peritoneal cancer, or fallopian tube cancer received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with EOC primary peritoneal cancer or fallopian tube cancer (that had relapsed following platinum-based therapy, excluding those participants with primary platinum refractory disease or low grade or clear cell ovarian cancer) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
BG016
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0002
BG0011
BG0021
BG0031
BG0049
BG00518
BG0067
BG0075
BG0085
BG0094
BG0109
BG0117
BG01246
BG01324
BG01427
BG01540
BG016206
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0011
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
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
Dose-Escalation Phase: Maximum Tolerated Dose (MTD) of Mirvetuximab Soravtansine
MTD was defined as the highest dose at which 1 or fewer among 6 participants or less than or equal to (<=) 33 percent (%) experienced a dose-limiting toxicity (DLT) (calculated based on adjusted ideal body weight [AIBW]). AIBW was calculated as ideal body weight (IBW) + 0.4 * (actual weight - IBW), where IBW for men was 0.9 * height in centimeters (cm) - 88 and IBW for women was 0.9 * height in cm - 92. DLT was defined as a treatment-emergent adverse event (TEAE) or abnormal laboratory value related to study treatment (that is, assessed as unrelated to disease, intercurrent illness, or concomitant medications), including those TEAEs and abnormal laboratory values that resulted in a failure to meet the criteria for re-treatment.
Safety population included all participants who were enrolled and received at least 1 dose of study drug.
Posted
Number
mg/kg
Cycle 1 (21 days)
ID
Title
Description
OG000
Dose Escalation: Schedule A (Mirvetuximab Soravtansine Q3W)
Participants received mirvetuximab soravtansine IV infusion on Day 1 of every 21-day (Q3W) cycle. Dose escalation started at 0.15 mg/kg and proceeded through 7.0 mg/kg. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG001
Dose Escalation: Schedule B (Mirvetuximab Soravtansine Weekly)
Participants received mirvetuximab soravtansine IV infusion on Days 1, 8, and 15 of every 28-day cycle. Dose escalation started at 1.1 mg/kg and proceeded through 2.5 mg/kg. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Units
Counts
Participants
OG00044
OG00125
Title
Denominators
Categories
Title
Measurements
OG0006.0
OG0012.0
Primary
Dose-Escalation Phase: Recommended Phase 2 Dose (RP2D) of Mirvetuximab Soravtansine
RP2D was determined by MTD. MTD was defined as the highest dose at which 1 or fewer among 6 participants or <=33% experienced a DLT. DLT was defined as a TEAE or abnormal laboratory value related to study treatment (that is, assessed as unrelated to disease, intercurrent illness, or concomitant medications), including those TEAEs and abnormal laboratory values that resulted in a failure to meet the criteria for re-treatment. Available clinical data indicated that the MTD defined for the Q3W schedule was equal to the RP2D.
Safety population included all participants who were enrolled and received at least 1 dose of study drug.
Posted
Number
mg/kg
Cycle 1 (21 days)
ID
Title
Description
OG000
Dose Escalation: Schedule A (Mirvetuximab Soravtansine Q3W)
Participants received mirvetuximab soravtansine IV infusion on Day 1 of every 21-day (Q3W) cycle. Dose escalation started at 0.15 mg/kg and proceeded through 7.0 mg/kg. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Units
Counts
Participants
Secondary
Number of Participants With TEAEs
An adverse event (AE) was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to study drug. Severity was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03 on following scale: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening, Grade 5=death. Serious AEs include death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as any AE that emerged on or after the first dose, and within 28 days of the last dose.
Safety population included all participants who were enrolled and received at least 1 dose of study drug.
Posted
Count of Participants
Participants
From first dose of study drug up to 28 days after last dose of study drug (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)
ID
Title
Description
OG000
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W)
Participants received mirvetuximab soravtansine 0.15 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Secondary
Number of Participants With Shift From Baseline Grade <=2 in Clinical Laboratory Parameters to Grade 3 or Grade 4 on Study
Laboratory parameters included serum chemistry (alanine aminotransferase [ALT]/serum glutamic pyruvic transaminase [SGPT], aspartate aminotransferase [AST]/serum glutamic oxaloacetic transaminase [SGOT], albumin, alkaline phosphatase, bilirubin, calcium, creatinine, glucose, magnesium, phosphorous, potassium, sodium), hematology (hemoglobin, lymphocytes, neutrophils, platelets, white blood cells) and coagulation (international normalized ratio [INR], partial thromboplastin time [PTT]). Clinically significant laboratory values were defined as per NCI CTCAE v.03 Grade 3 or higher. A grading (severity) scale was provided with grades ranging from 0 (none), 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening or disabling), to 5 (death). Only participants who shifted from a baseline value of Grade <=2 to a post-baseline Grade 3/4 on-treatment, are reported.
Safety population included all participants who were enrolled and received at least 1 dose of study drug.
Posted
Count of Participants
Participants
From first dose of study drug up to 28 days after last dose of study drug (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)
ID
Title
Description
OG000
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W)
Participants received mirvetuximab soravtansine 0.15 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Secondary
Number of Participants With Clinically Significant Abnormalities in Physical Examination Findings and Vital Signs
Physical examination included assessments of general appearance, skin, head (eyes, ears, nose, and throat), neck, lungs, heart, abdomen, back, lymph nodes, extremities, and neurological system. Vital signs included assessment of blood pressure, pulse rate, respiratory rate and body temperature.
Safety population included all participants who were enrolled and received at least 1 dose of study drug.
Posted
Count of Participants
Participants
From first dose of study drug up to 28 days after last dose of study drug (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)
ID
Title
Description
OG000
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W)
Participants received mirvetuximab soravtansine 0.15 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG001
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W)
Participants received mirvetuximab soravtansine 0.5 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Secondary
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG)
Standard ECGs were performed in triplicate at 2- to 5-minute intervals during the study. A single ECG was performed at the end of treatment visit and as clinically indicated.
Safety population included all participants who were enrolled and received at least 1 dose of study drug.
Posted
Count of Participants
Participants
Baseline up to end of treatment (EOT) (up to maximum 124 weeks)
ID
Title
Description
OG000
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W)
Participants received mirvetuximab soravtansine 0.15 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG001
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W)
Participants received mirvetuximab soravtansine 0.5 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG002
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W)
Secondary
Number of Participants With Treatment-Emergent Ocular AEs
Ocular AEs included keratopathy and blurred vision. An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to study drug. TEAEs were defined as any AE that emerged on or after the first dose, and within 28 days of the last dose.
Safety population included all participants who were enrolled and received at least 1 dose of study drug.
Posted
Count of Participants
Participants
From first dose of study drug up to 28 days after last dose of study drug (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)
ID
Title
Description
OG000
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W)
Participants received mirvetuximab soravtansine 0.15 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG001
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W)
Participants received mirvetuximab soravtansine 0.5 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Secondary
Maximum Observed Plasma Concentration (Cmax) of Mirvetuximab Soravtansine and Total M9346A Antibody at RP2D
Pharmacokinetic (PK) parameters were calculated using standard non-compartmental methods. PK analysis of mirvetuximab soravtansine and total M9346A antibody is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.
PK Population included all participants who received at least 1 infusion of mirvetuximab soravtansine and had evaluable PK data. 'Overall number of participants analyzed' = participants who received mirvetuximab soravtansine at 6 mg/kg AIBW. 'Number analyzed' = participants evaluable for this outcome for specified categories.
Posted
Mean
Standard Deviation
micrograms per milliliter (mcg/mL)
Cycle 1, 3: Day 1 (pre-infusion; within 10 minutes [min] of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion)
ID
Title
Description
OG000
Mirvetuximab Soravtansine 6.0 mg/kg AIBW
Participants received mirvetuximab soravtansine 6.0 mg/kg (calculated based on AIBW) on Day 1 of Cycle 1 and Cycle 3.
Units
Counts
Participants
OG000
Secondary
Cmax of Free DM4 and S-Methyl DM4 at RP2D
PK parameters were calculated using standard non-compartmental methods. PK analysis of free N2'-[4-[(3-carboxypropyl)dithio]-4-methyl-1-oxo-2-sulfopentyl]-N2'-deacetylmaytansine (DM4) and S-methyl DM4 is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.
PK Population included all participants who received at least 1 infusion of mirvetuximab soravtansine and had evaluable PK data. 'Overall number of participants analyzed' = participants who received mirvetuximab soravtansine at 6 mg/kg AIBW. 'Number analyzed' = participants evaluable for this outcome for specified categories.
Posted
Mean
Standard Deviation
nanograms per milliliter (ng/mL)
Cycle 1, 3: Day 1 (pre-infusion; within 10 min of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion)
ID
Title
Description
OG000
Mirvetuximab Soravtansine 6.0 mg/kg AIBW
Participants received mirvetuximab soravtansine 6.0 mg/kg (calculated based on AIBW) on Day 1 of Cycle 1 and Cycle 3.
Units
Counts
Participants
OG000
Secondary
Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) of Mirvetuximab Soravtansine and Total M9346A Antibody at RP2D
PK parameters were calculated using standard non-compartmental methods. PK analysis of mirvetuximab soravtansine and total M9346A antibody is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.
PK Population included all participants who received at least 1 infusion of mirvetuximab soravtansine and had evaluable PK data. 'Overall number of participants analyzed' = participants who received mirvetuximab soravtansine at 6 mg/kg AIBW. 'Number analyzed' = participants evaluable for this outcome for specified categories.
Posted
Mean
Standard Deviation
hours*milligrams/milliliter (hr*mg/mL)
Cycle 1, 3: Day 1 (pre-infusion; within 10 min of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion)
ID
Title
Description
OG000
Mirvetuximab Soravtansine 6.0 mg/kg AIBW
Participants received mirvetuximab soravtansine 6.0 mg/kg (calculated based on AIBW) on Day 1 of Cycle 1 and Cycle 3.
Units
Counts
Participants
Secondary
AUC0-inf of Free DM4 and S-Methyl DM4 at RP2D
PK parameters were calculated using standard non-compartmental methods. PK analysis of free DM4 and S-methyl DM4 is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.
PK Population included all participants who received at least 1 infusion of mirvetuximab soravtansine and had evaluable PK data. 'Overall number of participants analyzed' = participants who received mirvetuximab soravtansine at 6 mg/kg AIBW. 'Number analyzed' = participants evaluable for this outcome for specified categories.
Posted
Mean
Standard Deviation
hours*nanograms/milliliter (hr*ng/mL)
Cycle 1, 3: Day 1 (pre-infusion; within 10 min of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion)
ID
Title
Description
OG000
Mirvetuximab Soravtansine 6.0 mg/kg AIBW
Participants received mirvetuximab soravtansine 6.0 mg/kg (calculated based on AIBW) on Day 1 of Cycle 1 and Cycle 3.
Units
Counts
Participants
OG000
Secondary
Area Under the Plasma Concentration-Versus Time Curve From Time of Dose Until Tlast (AUClast) of Mirvetuximab Soravtansine and Total M9346A Antibody at RP2D
PK parameters were calculated using standard non-compartmental methods. PK analysis of mirvetuximab soravtansine and total M9346A antibody is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.
PK Population included all participants who received at least 1 infusion of mirvetuximab soravtansine and had evaluable PK data. 'Overall number of participants analyzed' = participants who received mirvetuximab soravtansine at 6 mg/kg AIBW. 'Number analyzed' = participants evaluable for this outcome for specified categories.
Posted
Mean
Standard Deviation
hr*mg/mL
Cycle 1, 3: Day 1 (pre-infusion; within 10 min of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion)
ID
Title
Description
OG000
Mirvetuximab Soravtansine 6.0 mg/kg AIBW
Participants received mirvetuximab soravtansine 6.0 mg/kg (calculated based on AIBW) on Day 1 of Cycle 1 and Cycle 3.
Units
Counts
Participants
OG000
Secondary
AUClast of Free DM4 and S-Methyl DM4 at RP2D
PK parameters were calculated using standard non-compartmental methods. PK analysis of free DM4 and S-methyl DM4 is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.
PK Population included all participants who received at least 1 infusion of mirvetuximab soravtansine and had evaluable PK data. 'Overall number of participants analyzed' = participants who received mirvetuximab soravtansine at 6 mg/kg AIBW. 'Number analyzed' = participants evaluable for this outcome for specified categories.
Posted
Mean
Standard Deviation
hr*ng/mL
Cycle 1, 3: Day 1 (pre-infusion; within 10 min of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion)
ID
Title
Description
OG000
Mirvetuximab Soravtansine 6.0 mg/kg AIBW
Participants received mirvetuximab soravtansine 6.0 mg/kg (calculated based on AIBW) on Day 1 of Cycle 1 and Cycle 3.
Units
Counts
Participants
OG000
Secondary
Terminal Half-Life (t1/2) of Mirvetuximab Soravtansine,Total M9346A Antibody, DM4, and S-Methyl DM4 at RP2D
PK parameters were calculated using standard non-compartmental methods. PK analysis of mirvetuximab soravtansine, total M9346A antibody, DM4, and S-methyl DM4 is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.
PK Population included all participants who received at least 1 infusion of mirvetuximab soravtansine and had evaluable PK data. 'Overall number of participants analyzed' = participants who received mirvetuximab soravtansine at 6 mg/kg AIBW. 'Number analyzed' = participants evaluable for this outcome for specified categories.
Posted
Mean
Standard Deviation
hours
Cycle 1, 3: Day 1 (pre-infusion; within 10 min of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion)
ID
Title
Description
OG000
Mirvetuximab Soravtansine 6.0 mg/kg AIBW
Participants received mirvetuximab soravtansine 6.0 mg/kg (calculated based on AIBW) on Day 1 of Cycle 1 and Cycle 3.
Units
Counts
Participants
OG000
Secondary
Clearance (CL) of Mirvetuximab Soravtansine and Total M9346A Antibody at RP2D
PK parameters were calculated using standard non-compartmental methods. PK analysis of mirvetuximab soravtansine and total M9346A antibody is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.
PK Population included all participants who received at least 1 infusion of mirvetuximab soravtansine and had evaluable PK data. 'Overall number of participants analyzed' = participants who received mirvetuximab soravtansine at 6 mg/kg AIBW. 'Number analyzed' = participants evaluable for this outcome for specified categories.
Posted
Mean
Standard Deviation
milliliters per hour (mL/hr)
Cycle 1, 3: Day 1 (pre-infusion; within 10 min of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion)
ID
Title
Description
OG000
Mirvetuximab Soravtansine 6.0 mg/kg AIBW
Participants received mirvetuximab soravtansine 6.0 mg/kg (calculated based on AIBW) on Day 1 of Cycle 1 and Cycle 3.
Units
Counts
Participants
OG000
Secondary
CL of DM4 and S-Methyl DM4 at RP2D
PK parameters were calculated using standard non-compartmental methods. PK analysis of DM4 and S-methyl DM4 is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.
PK Population included all participants who received at least 1 infusion of mirvetuximab soravtansine and had evaluable PK data. 'Overall number of participants analyzed' = participants who received mirvetuximab soravtansine at 6 mg/kg AIBW. 'Number analyzed' = participants evaluable for this outcome for specified categories.
Posted
Mean
Standard Deviation
Liters per hour (L/hr)
Cycle 1, 3: Day 1 (pre-infusion; within 10 min of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion)
ID
Title
Description
OG000
Mirvetuximab Soravtansine 6.0 mg/kg AIBW
Participants received mirvetuximab soravtansine 6.0 mg/kg (calculated based on AIBW) on Day 1 of Cycle 1 and Cycle 3.
Units
Counts
Participants
OG000
Secondary
Time to Reach Maximum Observed Concentration (Tmax) of Mirvetuximab Soravtansine, Free DM4, S-Methyl DM4, and Total M9346A Antibody at RP2D
PK parameters were calculated using standard non-compartmental methods. PK analysis of mirvetuximab soravtansine, free DM4, S-methyl DM4, and total M9346A antibody is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.
PK Population included all participants who received at least 1 infusion of mirvetuximab soravtansine and had evaluable PK data. 'Overall number of participants analyzed' = participants who received mirvetuximab soravtansine at 6 mg/kg AIBW. 'Number analyzed' = participants evaluable for this outcome for specified categories.
Posted
Median
Full Range
hours
Cycle 1, 3: Day 1 (pre-infusion; within 10 min of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion)
ID
Title
Description
OG000
Mirvetuximab Soravtansine 6.0 mg/kg AIBW
Participants received mirvetuximab soravtansine 6.0 mg/kg (calculated based on AIBW) on Day 1 of Cycle 1 and Cycle 3.
Units
Counts
Participants
OG000
Secondary
Volume of Distribution at Steady State (Vss) of Mirvetuximab Soravtansine Free DM4, S-Methyl DM4, and Total M9346A Antibody at RP2D
PK parameters were calculated using standard non-compartmental methods. PK analysis of mirvetuximab soravtansine, free DM4, S-methyl DM4, and total M9346A antibody is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.
PK Population included all participants who received at least 1 infusion of mirvetuximab soravtansine and had evaluable PK data. 'Overall number of participants analyzed' = participants who received mirvetuximab soravtansine at 6 mg/kg AIBW. 'Number analyzed' = participants evaluable for this outcome for specified categories.
Posted
Mean
Standard Deviation
Liters
Cycle 1, 3: Day 1 (pre-infusion; within 10 min of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion)
ID
Title
Description
OG000
Mirvetuximab Soravtansine 6.0 mg/kg AIBW
Participants received mirvetuximab soravtansine 6.0 mg/kg (calculated based on AIBW) on Day 1 of Cycle 1 and Cycle 3.
Units
Counts
Participants
OG000
Secondary
Objective Response Rate (ORR): Percentage of Participants With Objective Response as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
ORR was defined as percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). CR: Disappearance of all target or non-target lesions. All pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm). PR: At least 30 percent (%) decrease in the sum of the longest diameters (SoD) of target lesions, taking as reference the baseline SoD.
Efficacy-evaluable population included participants who had radiographic assessment at baseline, received at least 1 dose of study drug, and had at least 1 post-dose tumor assessment or died or clinically progressed within 105 days of last dose. Data was only collected and reported combined for dose-escalation phase and not by individual doses.
Posted
Number
95% Confidence Interval
percentage of participants
From first dose of study drug until first BOR of CR or PR (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)
ID
Title
Description
OG000
Dose Escalation: Schedule A (Mirvetuximab Soravtansine Q3W)
Participants received mirvetuximab soravtansine IV infusion on Day 1 of every 21-day (Q3W) cycle. Dose escalation started at 0.15 mg/kg and proceeded through 7.0 mg/kg. Doses calculated initially based on participant's TBW; then from protocol amendment 5 onwards, calculated based on AIBW. The doses evaluated during dose escalation for Schedule A, TBW were: 0.15 mg/kg (n=2); 0.5 mg/kg; 1.0 mg/kg, and 2.0 mg/kg (n=1, in each); 3.3 mg/kg (n=9); 5.0 mg/kg (n=11); and 7.0 mg/kg (n=5). The doses evaluated during dose escalation for Schedule A, AIBW were: 5.0 mg/kg (n=7); and 6 mg/kg (n=7). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Secondary
Duration of Response (DOR) as Assessed by RECIST v1.1
DOR was defined as the time from the date of the first response (CR or PR), whichever was recorded first, until the date of progressive disease (PD). PD: At least a 20% increase in the SoD of target lesion, taken as reference the smallest (nadir) SoD since and including baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase. DOR was only defined for participants who had a BOR of CR or PR using the method of Kaplan-Meier.
Efficacy-evaluable population included participants who had radiographic assessment at baseline, received at least 1 dose of study drug, and had at least 1 post-dose tumor assessment or died or clinically progressed within 105 days of last dose. 'Overall number of participants analyzed'=participants who had a BOR of CR or PR. Data by group only.
Posted
Median
95% Confidence Interval
weeks
From the date of first response (CR or PR) until the date of PD (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)
ID
Title
Description
OG000
Dose Escalation: Schedule A (Mirvetuximab Soravtansine Q3W)
Participants received mirvetuximab soravtansine IV infusion on Day 1 of every 21-day (Q3W) cycle. Dose escalation started at 0.15 mg/kg and proceeded through 7.0 mg/kg. Doses calculated initially based on participant's TBW; then from protocol amendment 5 onwards, calculated based on AIBW. The doses evaluated during dose escalation for Schedule A, TBW were: 0.15 mg/kg (n=2); 0.5 mg/kg; 1.0 mg/kg, and 2.0 mg/kg (n=1, in each); 3.3 mg/kg (n=9); 5.0 mg/kg (n=11); and 7.0 mg/kg (n=5). The doses evaluated during dose escalation for Schedule A, AIBW were: 5.0 mg/kg (n=7); and 6 mg/kg (n=7). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Secondary
Progression-Free Survival (PFS) as Assessed by RECIST v1.1
PFS was defined as the time from initiation of study drug until PD or death whichever occurred first, estimated using the Kaplan-Meier method. PD: At least a 20% increase in the SoD of target lesion, taken as reference the smallest (nadir) SoD since and including baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of non-target lesions and appearance of new lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.
Efficacy-evaluable population included participants who had radiographic assessment at baseline, received at least 1 dose of study drug, and had at least 1 post-dose tumor assessment or died or clinically progressed within 105 days of last dose. Data was only collected and reported combined for dose-escalation phase and not by individual doses.
Posted
Median
95% Confidence Interval
months
From first dose of study drug until PD or death whichever occurred first (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)
ID
Title
Description
OG000
Dose Escalation: Schedule A (Mirvetuximab Soravtansine Q3W)
Participants received mirvetuximab soravtansine IV infusion on Day 1 of every 21-day (Q3W) cycle. Dose escalation started at 0.15 mg/kg and proceeded through 7.0 mg/kg. Doses calculated initially based on participant's TBW; then from protocol amendment 5 onwards, calculated based on AIBW. The doses evaluated during dose escalation for Schedule A, TBW were: 0.15 mg/kg (n=2); 0.5 mg/kg; 1.0 mg/kg, and 2.0 mg/kg (n=1, in each); 3.3 mg/kg (n=9); 5.0 mg/kg (n=11); and 7.0 mg/kg (n=5). The doses evaluated during dose escalation for Schedule A, AIBW were: 5.0 mg/kg (n=7); and 6 mg/kg (n=7). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Secondary
Time to Progression (TTP) as Assessed by RECIST v1.1
TTP was defined as the time from initiation of study drug until PD, estimated using the method of Kaplan-Meier. PD: At least a 20% increase in the SoD of target lesion, taken as reference the smallest (nadir) SoD since and including baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of non-target lesions and appearance of new lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.
Efficacy-evaluable population included participants who had radiographic assessment at baseline, received at least 1 dose of study drug, and had at least 1 post-dose tumor assessment or died or clinically progressed within 105 days of last dose. Data was only collected and reported combined for dose-escalation phase and not by individual doses.
Posted
Median
95% Confidence Interval
months
From first dose of study drug until PD (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)
ID
Title
Description
OG000
Dose Escalation: Schedule A (Mirvetuximab Soravtansine Q3W)
Participants received mirvetuximab soravtansine IV infusion on Day 1 of every 21-day (Q3W) cycle. Dose escalation started at 0.15 mg/kg and proceeded through 7.0 mg/kg. Doses calculated initially based on participant's TBW; then from protocol amendment 5 onwards, calculated based on AIBW. The doses evaluated during dose escalation for Schedule A, TBW were: 0.15 mg/kg (n=2); 0.5 mg/kg; 1.0 mg/kg, and 2.0 mg/kg (n=1, in each); 3.3 mg/kg (n=9); 5.0 mg/kg (n=11); and 7.0 mg/kg (n=5). The doses evaluated during dose escalation for Schedule A, AIBW were: 5.0 mg/kg (n=7); and 6 mg/kg (n=7). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Secondary
Number of Participants With Anti-Drug Antibodies (ADA)
During the conduct of the study, a single immunogenicity assay was developed to concurrently detect human antibodies against all components of mirvetuximab soravtansine, including the humanized anti-FOLR1 antibody, the cleavable disulfide linker, and the cytotoxic maytansinoid, DM4. Therefore, immunogenicity results were reported as ADA titers, and did not distinguish between human anti-drug or anti-human titers.
Immunogenicity population included all participants who received at least 1 infusion of mirvetuximab soravtansine and had evaluable immunogenicity data.
Posted
Count of Participants
Participants
Baseline up to follow-up visit (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)
ID
Title
Description
OG000
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W)
Participants received mirvetuximab soravtansine 0.15 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG001
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W)
Participants received mirvetuximab soravtansine 0.5 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Secondary
Number of Participants With Gynecologic Cancer Intergroup (GCIG) CA-125 Criteria Clinical Responses
CA-125 response was defined as at least 50% reduction in CA-125 levels from baseline. The date of response corresponded to the date when the CA 125 level was first reduced by 50%.
CA-125 evaluable population included participants who had a baseline CA-125 value greater than or equal to (>=) 2 * upper limit of normal (ULN), received at least 1 dose of study drug, and had at least 1 post-dose CA-125 assessment.
Posted
Count of Participants
Participants
From first dose of study drug until CA-125 response (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)
ID
Title
Description
OG000
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W)
Participants received mirvetuximab soravtansine 0.15 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG001
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W)
Participants received mirvetuximab soravtansine 0.5 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Time Frame
From first dose of study drug up to 28 days after last dose of study drug (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)
Description
Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data was only collected and reported by combined groups for the dose-escalation phase and not by individual doses.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W)
Participants received mirvetuximab soravtansine 0.15 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
2
2
2
2
2
2
EG001
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W)
Participants received mirvetuximab soravtansine 0.5 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
0
1
0
1
0
1
EG002
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 1.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
0
1
1
1
1
1
EG003
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
0
1
0
1
1
1
EG004
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W)
Participants received mirvetuximab soravtansine 3.3 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
0
9
0
9
9
9
EG005
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 5.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
1
18
5
18
18
18
EG006
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 6.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
0
7
1
7
7
7
EG007
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 7.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
0
5
2
5
5
5
EG008
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly)
Participants received mirvetuximab soravtansine 1.1 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
0
5
2
5
5
5
EG009
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly)
Participants received mirvetuximab soravtansine 1.8 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
0
4
3
4
4
4
EG010
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly)
Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
1
9
4
9
9
9
EG011
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly)
Participants received mirvetuximab soravtansine 2.5 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with EOC, primary peritoneal cancer, or fallopian tube cancer resistant to platinum-based therapy received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with FOLR1-positive uterine cancer (that was advanced or recurrent and had received at least 1 platinum-based regimen, and no more than 5 prior systemic treatment regimens for EC) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with biopsy-accessible relapsed or refractory ovarian cancer, primary peritoneal cancer, or fallopian tube cancer received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with EOC primary peritoneal cancer or fallopian tube cancer (that had relapsed following platinum-based therapy, excluding those participants with primary platinum refractory disease or low grade or clear cell ovarian cancer) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
4
40
17
40
40
40
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0021 affected1 at risk
EG0030 affected1 at risk
EG0040 affected9 at risk
EG0051 affected18 at risk
EG0060 affected7 at risk
EG0070 affected5 at risk
EG0080 affected5 at risk
EG0091 affected4 at risk
EG0101 affected9 at risk
EG0110 affected7 at risk
EG0122 affected46 at risk
EG0130 affected24 at risk
EG0140 affected27 at risk
EG0157 affected40 at risk
Gastritis
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Corneal opacity
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Punctate keratitis
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Metastatic neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Organising pneumonia
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Influenza
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Pulmonary embolism
Renal and urinary disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Superior vena cava syndrome
Vascular disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Large intestinal obstruction
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Enterocutaneous fistula
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Asthenia
General disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Fatigue
General disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Pyrexia
General disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Gallbladder obstruction
Hepatobiliary disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Abdominal wall abscess
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Cystitis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Device related infection
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Haemophilus infection
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Septic shock
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Wound infection
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Metastases to meninges
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Pulmonary fibrosis
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Hypotension
Vascular disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG0030 affected1 at risk
EG0043 affected9 at risk
EG0057 affected18 at risk
EG0062 affected7 at risk
EG0072 affected5 at risk
EG0082 affected5 at risk
EG0091 affected4 at risk
EG0105 affected9 at risk
EG0113 affected7 at risk
EG01224 affected46 at risk
EG0138 affected24 at risk
EG01410 affected27 at risk
EG01523 affected40 at risk
Nausea
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0021 affected1 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Oral dysaesthesia
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Retching
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Vision blurred
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Visual impairment
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Diplopia
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Punctate keratitis
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Corneal erosion
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Corneal pigmentation
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Eye disorder
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Eye irritation
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Eye pain
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Macular degeneration
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Photophobia
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Retinal haemorrhage
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Retinopathy
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Vitreous floaters
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Fatigue
General disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Pyrexia
General disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Chills
General disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Oedema peripheral
General disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Asthenia
General disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Pain
General disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Headache
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Aphasia
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Facial neuralgia
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Hypogeusia
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Peripheral motor neuropathy
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Tremor
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Weight decreased
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Breath sounds abnormal
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Paranasal sinus hypersecretion
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Sinus disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Upper respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Eye infection
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Eye infection bacterial
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Hordeolum
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Sweating fever
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Restlessness
Psychiatric disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Eye contusion
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Wound complication
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Pelvic discomfort
Reproductive system and breast disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Vulvovaginal erythema
Reproductive system and breast disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Hypertension
Vascular disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Hot flush
Vascular disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Phlebitis
Vascular disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Inner ear disorder
Ear and labyrinth disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Abdominal hernia
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Disturbance in attention
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Catheter site pain
General disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Influenza like illness
General disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Joint range of motion decreased
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Osteopenia
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Throat irritation
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Blood urea increased
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Oxygen saturation decreased
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Vitamin D decreased
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Weight increased
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Dry eye
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Cataract
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Conjunctival haemorrhage
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Corneal deposits
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Eye pruritus
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Keratopathy
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Ocular discomfort
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Photopsia
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Metabolic alkalosis
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Polydipsia
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Chronic pigmented purpura
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Nail disorder
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Candida infection
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Cystitis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Fungal infection
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Pneumonia staphylococcal
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
External ear inflammation
Ear and labyrinth disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Flushing
Vascular disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Hypotension
Vascular disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Depression
Psychiatric disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Micturition urgency
Renal and urinary disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Thyroid pain
Endocrine disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Breast mass
Reproductive system and breast disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Abdominal rigidity
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Anorectal discomfort
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Hypoaesthesia oral
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Large intestinal obstruction
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Lip haemorrhage
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Lip pain
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Mouth swelling
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Oral disorder
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Rectal discharge
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Tooth discolouration
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Early satiety
General disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Gait disturbance
General disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Malaise
General disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Infusion site extravasation
General disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Catheter site inflammation
General disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Catheter site rash
General disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Chest discomfort
General disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Infusion site discolouration
General disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Localised oedema
General disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Necrosis
General disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Nodule
General disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Performance status decreased
General disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Keratitis
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Corneal epithelial microcysts
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Corneal cyst
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Corneal disorder
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Vitreous degeneration
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Abnormal sensation in eye
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Asthenopia
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Blepharitis
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Chalazion
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Corneal lesion
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Corneal oedema
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Glaucoma
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Iritis
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Lacrimation decreased
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Lagophthalmos
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Macular fibrosis
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Posterior capsule opacification
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Retinal vein occlusion
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Visual acuity reduced
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Vitreous adhesions
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Vitreous detachment
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Brain oedema
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Burning sensation
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Depressed level of consciousness
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Hyperreflexia
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Migraine
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Nystagmus
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Restless legs syndrome
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Glucose tolerance impaired
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Hypermagnesaemia
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Platelet count decreased
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Blood magnesium decreased
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Blood potassium decreased
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Eastern Cooperative Oncology Group performance status worsened
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Carbon monoxide diffusing capacity decreased
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Gastrointestinal stoma output decreased
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Intraocular pressure increased
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Lymph node palpable
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Protein total decreased
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Waist circumference increased
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Diaphragmalgia
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Sinus pain
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Coccydynia
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Limb discomfort
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Skin infection
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Device related infection
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Sepsis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Angular cheilitis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Eye infection fungal
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Paronychia
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Vulvitis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Wound infection
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Corneal abrasion
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Anastomotic ulcer
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Excoriation
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Laceration
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Post procedural diarrhoea
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Stomal hernia
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Vascular access complication
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Wound dehiscence
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Increased tendency to bruise
Blood and lymphatic system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Pain of skin
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Swelling face
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Telangiectasia
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Bladder spasm
Renal and urinary disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Nocturia
Renal and urinary disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Urinary hesitation
Renal and urinary disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Urinary tract pain
Renal and urinary disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Arterial intramural haematoma
Vascular disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Haematoma
Vascular disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Agitation
Psychiatric disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Vaginal discharge
Reproductive system and breast disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Breast pain
Reproductive system and breast disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Vulvovaginal dryness
Reproductive system and breast disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Perineal rash
Reproductive system and breast disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Vaginal lesion
Reproductive system and breast disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Vulvovaginal discomfort
Reproductive system and breast disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Vulvovaginal pruritus
Reproductive system and breast disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Right ventricular hypertrophy
Cardiac disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Ear discomfort
Ear and labyrinth disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Otorrhoea
Ear and labyrinth disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Hepatic pain
Hepatobiliary disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Portal hypertension
Hepatobiliary disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Metastatic neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
Adenoma benign
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W)
Participants received mirvetuximab soravtansine 0.5 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG002
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 1.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG003
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG004
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W)
Participants received mirvetuximab soravtansine 3.3 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG005
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 5.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG006
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 6.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG007
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 7.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG008
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly)
Participants received mirvetuximab soravtansine 1.1 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG009
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly)
Participants received mirvetuximab soravtansine 1.8 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG010
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly)
Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG011
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly)
Participants received mirvetuximab soravtansine 2.5 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with EOC, primary peritoneal cancer, or fallopian tube cancer resistant to platinum-based therapy received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with FOLR1-positive uterine cancer (that was advanced or recurrent and had received at least 1 platinum-based regimen, and no more than 5 prior systemic treatment regimens for EC) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with biopsy-accessible relapsed or refractory ovarian cancer, primary peritoneal cancer, or fallopian tube cancer received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with EOC primary peritoneal cancer or fallopian tube cancer (that had relapsed following platinum-based therapy, excluding those participants with primary platinum refractory disease or low grade or clear cell ovarian cancer) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Units
Counts
Participants
OG0002
OG0011
OG0021
OG0031
OG0049
OG00518
OG0067
OG0075
OG0085
OG0094
OG0109
OG0117
OG01246
OG01324
OG01427
OG01540
Title
Denominators
Categories
Any TEAE
Title
Measurements
OG0002
OG0011
OG0020
OG0031
OG0049
OG00518
OG0067
OG0075
OG0085
OG0094
OG0109
OG0117
OG01246
OG01324
OG01427
OG01540
SAEs
Title
Measurements
OG0002
OG0011
OG0020
OG003
Grade >=3 TEAEs
Title
Measurements
OG0002
OG0011
OG0020
OG003
OG001
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W)
Participants received mirvetuximab soravtansine 0.5 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG002
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 1.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG003
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG004
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W)
Participants received mirvetuximab soravtansine 3.3 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG005
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 5.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG006
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 6.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG007
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 7.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG008
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly)
Participants received mirvetuximab soravtansine 1.1 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG009
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly)
Participants received mirvetuximab soravtansine 1.8 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG010
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly)
Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG011
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly)
Participants received mirvetuximab soravtansine 2.5 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with EOC, primary peritoneal cancer, or fallopian tube cancer resistant to platinum-based therapy received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with FOLR1-positive uterine cancer (that was advanced or recurrent and had received at least 1 platinum-based regimen, and no more than 5 prior systemic treatment regimens for EC) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with biopsy-accessible relapsed or refractory ovarian cancer, primary peritoneal cancer, or fallopian tube cancer received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with EOC primary peritoneal cancer or fallopian tube cancer (that had relapsed following platinum-based therapy, excluding those participants with primary platinum refractory disease or low grade or clear cell ovarian cancer) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Units
Counts
Participants
OG0002
OG0011
OG0021
OG0031
OG0049
OG00518
OG0067
OG0075
OG0085
OG0094
OG0109
OG0117
OG01246
OG01324
OG01427
OG01540
Title
Denominators
Categories
Glucose: Grade 0 to Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0121
OG0130
OG0140
OG0150
Magnesium: Grade 2 to Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
PTT: Grade 2 to Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Lymphocytes: Grade 0 to Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Lymphocytes: Grade 2 to Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG002
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 1.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG003
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG004
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W)
Participants received mirvetuximab soravtansine 3.3 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG005
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 5.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG006
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 6.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG007
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 7.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG008
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly)
Participants received mirvetuximab soravtansine 1.1 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG009
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly)
Participants received mirvetuximab soravtansine 1.8 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG010
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly)
Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG011
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly)
Participants received mirvetuximab soravtansine 2.5 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with EOC, primary peritoneal cancer, or fallopian tube cancer resistant to platinum-based therapy received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with FOLR1-positive uterine cancer (that was advanced or recurrent and had received at least 1 platinum-based regimen, and no more than 5 prior systemic treatment regimens for EC) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with biopsy-accessible relapsed or refractory ovarian cancer, primary peritoneal cancer, or fallopian tube cancer received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with EOC primary peritoneal cancer or fallopian tube cancer (that had relapsed following platinum-based therapy, excluding those participants with primary platinum refractory disease or low grade or clear cell ovarian cancer) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Units
Counts
Participants
OG0002
OG0011
OG0021
OG0031
OG0049
OG00518
OG0067
OG0075
OG0085
OG0094
OG0109
OG0117
OG01246
OG01324
OG01427
OG01540
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
OG0140
OG0150
Participants received mirvetuximab soravtansine 1.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG003
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG004
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W)
Participants received mirvetuximab soravtansine 3.3 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG005
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 5.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG006
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 6.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG007
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 7.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG008
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly)
Participants received mirvetuximab soravtansine 1.1 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG009
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly)
Participants received mirvetuximab soravtansine 1.8 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG010
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly)
Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG011
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly)
Participants received mirvetuximab soravtansine 2.5 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with EOC, primary peritoneal cancer, or fallopian tube cancer resistant to platinum-based therapy received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with FOLR1-positive uterine cancer (that was advanced or recurrent and had received at least 1 platinum-based regimen, and no more than 5 prior systemic treatment regimens for EC) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with biopsy-accessible relapsed or refractory ovarian cancer, primary peritoneal cancer, or fallopian tube cancer received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with EOC primary peritoneal cancer or fallopian tube cancer (that had relapsed following platinum-based therapy, excluding those participants with primary platinum refractory disease or low grade or clear cell ovarian cancer) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Units
Counts
Participants
OG0002
OG0011
OG0021
OG0031
OG0049
OG00518
OG0067
OG0075
OG0085
OG0094
OG0109
OG0117
OG01246
OG01324
OG01427
OG01540
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0113
OG0122
OG0131
OG0141
OG0150
OG002
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 1.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG003
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG004
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W)
Participants received mirvetuximab soravtansine 3.3 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG005
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 5.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG006
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 6.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG007
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 7.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG008
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly)
Participants received mirvetuximab soravtansine 1.1 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG009
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly)
Participants received mirvetuximab soravtansine 1.8 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG010
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly)
Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG011
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly)
Participants received mirvetuximab soravtansine 2.5 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with EOC, primary peritoneal cancer, or fallopian tube cancer resistant to platinum-based therapy received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with FOLR1-positive uterine cancer (that was advanced or recurrent and had received at least 1 platinum-based regimen, and no more than 5 prior systemic treatment regimens for EC) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with biopsy-accessible relapsed or refractory ovarian cancer, primary peritoneal cancer, or fallopian tube cancer received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with EOC primary peritoneal cancer or fallopian tube cancer (that had relapsed following platinum-based therapy, excluding those participants with primary platinum refractory disease or low grade or clear cell ovarian cancer) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Units
Counts
Participants
OG0002
OG0011
OG0021
OG0031
OG0049
OG00518
OG0067
OG0075
OG0085
OG0094
OG0109
OG0117
OG01246
OG01324
OG01427
OG01540
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0054
OG0062
OG0075
OG0080
OG0093
OG0100
OG0112
OG01224
OG0139
OG01414
OG01518
142
Title
Denominators
Categories
Mirvetuximab soravtansine at Cycle 1
ParticipantsOG000142
Title
Measurements
OG000146.9± 30.14
Mirvetuximab soravtansine at Cycle 3
ParticipantsOG00090
Title
Measurements
OG000154.6± 33.08
Total M9346A antibody at Cycle 1
ParticipantsOG000142
Title
Measurements
OG000149.2± 33.74
Total M9346A antibody at Cycle 3
ParticipantsOG00090
Title
Measurements
OG000170.4± 40.55
142
Title
Denominators
Categories
DM4 at Cycle 1
ParticipantsOG00045
Title
Measurements
OG0005.014± 3.119
DM4 at Cycle 3
ParticipantsOG00035
Title
Measurements
OG0005.016± 2.389
S-methyl DM4 at Cycle 1
ParticipantsOG00045
Title
Measurements
OG00012.43± 12.39
S-methyl DM4 at Cycle 3
ParticipantsOG00035
Title
Measurements
OG0009.974± 5.485
OG000
142
Title
Denominators
Categories
Mirvetuximab soravtansine at Cycle 1
ParticipantsOG000142
Title
Measurements
OG00017.39± 4.341
Mirvetuximab soravtansine at Cycle 3
ParticipantsOG00087
Title
Measurements
OG00020.40± 5.144
Total M9346A antibody at Cycle 1
ParticipantsOG000142
Title
Measurements
OG00024.00± 7.316
Total M9346A antibody at Cycle 3
ParticipantsOG00087
Title
Measurements
OG00037.27± 12.54
142
Title
Denominators
Categories
DM4 at Cycle 1
ParticipantsOG00038
Title
Measurements
OG000292.9± 129.2
DM4 at Cycle 3
ParticipantsOG00027
Title
Measurements
OG000290.6± 98.52
S-methyl DM4 at Cycle 1
ParticipantsOG00039
Title
Measurements
OG0002656± 2722
S-methyl DM4 at Cycle 3
ParticipantsOG00027
Title
Measurements
OG0001928± 1108
142
Title
Denominators
Categories
Mirvetuximab soravtansine at Cycle 1
ParticipantsOG000142
Title
Measurements
OG00016.44± 4.177
Mirvetuximab soravtansine at Cycle 3
ParticipantsOG00087
Title
Measurements
OG00018.91± 4.940
Total M9346A antibody at Cycle 1
ParticipantsOG000142
Title
Measurements
OG00020.27± 5.903
Total M9346A antibody at Cycle 3
ParticipantsOG00087
Title
Measurements
OG00029.29± 9.613
142
Title
Denominators
Categories
DM4 at Cycle 1
ParticipantsOG00043
Title
Measurements
OG000246.0± 133.3
DM4 at Cycle 3
ParticipantsOG00027
Title
Measurements
OG000270.1± 95.62
S-methyl DM4 at Cycle 1
ParticipantsOG00045
Title
Measurements
OG0002485± 2536
S-methyl DM4 at Cycle 3
ParticipantsOG00027
Title
Measurements
OG0001806± 1046
142
Title
Denominators
Categories
Mirvetuximab soravtansine at Cycle 1
ParticipantsOG000142
Title
Measurements
OG000119.4± 22.58
Mirvetuximab soravtansine at Cycle 3
ParticipantsOG00090
Title
Measurements
OG000127.8± 34.11
Total M9346A antibody at Cycle 1
ParticipantsOG000142
Title
Measurements
OG000186.7± 54.04
Total M9346A antibody at Cycle 3
ParticipantsOG00090
Title
Measurements
OG000218.8± 71.46
DM4 at Cycle 1
ParticipantsOG00038
Title
Measurements
OG00073.80± 28.99
DM4 at Cycle 3
ParticipantsOG00030
Title
Measurements
OG00080.62± 26.12
S-methyl DM4 at Cycle 1
ParticipantsOG00039
Title
Measurements
OG000122.2± 25.23
S-methyl DM4 at Cycle 3
ParticipantsOG00032
Title
Measurements
OG000130.4± 23.47
142
Title
Denominators
Categories
Mirvetuximab soravtansine at Cycle 1
ParticipantsOG000141
Title
Measurements
OG00022.20± 6.476
Mirvetuximab soravtansine at Cycle 3
ParticipantsOG00087
Title
Measurements
OG00019.80± 4.953
Total M9346A antibody at Cycle 1
ParticipantsOG000141
Title
Measurements
OG00016.89± 7.155
Total M9346A antibody at Cycle 3
ParticipantsOG00087
Title
Measurements
OG00013.26± 4.956
142
Title
Denominators
Categories
DM4 at Cycle 1
ParticipantsOG00038
Title
Measurements
OG0001421± 560.2
DM4 at Cycle 3
ParticipantsOG00027
Title
Measurements
OG0001338± 438.8
S-methyl DM4 at Cycle 1
ParticipantsOG00039
Title
Measurements
OG000218.9± 128.5
S-methyl DM4 at Cycle 3
ParticipantsOG00027
Title
Measurements
OG000258.4± 173.8
142
Title
Denominators
Categories
Mirvetuximab soravtansine at Cycle 1
ParticipantsOG000142
Title
Measurements
OG0003.80(1.2 to 24)
Mirvetuximab soravtansine at Cycle 3
ParticipantsOG00090
Title
Measurements
OG0003.20(1.1 to 47)
Total M9346A antibody at Cycle 1
ParticipantsOG000142
Title
Measurements
OG0003.60(1.1 to 53)
Total M9346A antibody at Cycle 3
ParticipantsOG00090
Title
Measurements
OG0003.20(0.93 to 170)
DM4 at Cycle 1
ParticipantsOG00045
Title
Measurements
OG0005.80(1.7 to 500)
DM4 at Cycle 3
ParticipantsOG00035
Title
Measurements
OG0005.00(1.1 to 670)
S-methyl DM4 at Cycle 1
ParticipantsOG00045
Title
Measurements
OG00049.0(5.8 to 500)
S-methyl DM4 at Cycle 3
ParticipantsOG00035
Title
Measurements
OG00023.0(4.5 to 670)
142
Title
Denominators
Categories
Mirvetuximab soravtansine at Cycle 1
ParticipantsOG000141
Title
Measurements
OG0003.198± 0.7422
Mirvetuximab soravtansine at Cycle 3
ParticipantsOG00087
Title
Measurements
OG0003.172± 1.022
Total M9346A antibody at Cycle 1
ParticipantsOG000141
Title
Measurements
OG0003.744± 0.9183
Total M9346A antibody at Cycle 3
ParticipantsOG00087
Title
Measurements
OG0003.671± 1.185
DM4 at Cycle 1
ParticipantsOG00038
Title
Measurements
OG000107400± 38770
DM4 at Cycle 3
ParticipantsOG00027
Title
Measurements
OG000114300± 48740
S-methyl DM4 at Cycle 1
ParticipantsOG00039
Title
Measurements
OG00041590± 27890
S-methyl DM4 at Cycle 3
ParticipantsOG00027
Title
Measurements
OG00047520± 40440
OG001
Dose Escalation: Schedule B (Mirvetuximab Soravtansine Weekly)
Participants received mirvetuximab soravtansine IV infusion on Days 1, 8, and 15 of every 28-day cycle. Dose escalation started at 1.1 mg/kg and proceeded through 2.5 mg/kg (calculated based on AIBW). The doses evaluated during dose escalation for Schedule B, AIBW were: 1.1 mg/kg (n=5); 1.8 mg/kg (n=4), 2.0 mg/kg (n=9); and 2.5 mg/kg (n=7). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with EOC received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle (calculated based on AIBW). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with EC received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle (calculated based on AIBW). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Units
Counts
Participants
OG00043
OG00124
OG002113
OG00324
Title
Denominators
Categories
Title
Measurements
OG0005(0.6 to 15.8)
OG00113(2.7 to 32.4)
OG00230(21.8 to 39.4)
OG0038(1.0 to 27.0)
OG001
Dose Escalation: Schedule B (Mirvetuximab Soravtansine Weekly)
Participants received mirvetuximab soravtansine IV infusion on Days 1, 8, and 15 of every 28-day cycle. Dose escalation started at 1.1 mg/kg and proceeded through 2.5 mg/kg (calculated based on AIBW). The doses evaluated during dose escalation for Schedule B, AIBW were: 1.1 mg/kg (n=5); 1.8 mg/kg (n=4), 2.0 mg/kg (n=9); and 2.5 mg/kg (n=7). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with EOC received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle (calculated based on AIBW). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with EC received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle (calculated based on AIBW). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Units
Counts
Participants
OG0002
OG0013
OG00234
OG0032
Title
Denominators
Categories
Title
Measurements
OG00021.3(18.4 to 24.1)
OG00160.2(44.3 to 76.1)
OG00219.3(18.0 to 34.0)
OG00328.6(NA to NA)Due to smaller number of events, 95% CI could not be calculated.
OG001
Dose Escalation: Schedule B (Mirvetuximab Soravtansine Weekly)
Participants received mirvetuximab soravtansine IV infusion on Days 1, 8, and 15 of every 28-day cycle. Dose escalation started at 1.1 mg/kg and proceeded through 2.5 mg/kg (calculated based on AIBW). The doses evaluated during dose escalation for Schedule B, AIBW were: 1.1 mg/kg (n=5); 1.8 mg/kg (n=4), 2.0 mg/kg (n=9); and 2.5 mg/kg (n=7). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with EOC received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle (calculated based on AIBW). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with EC received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle (calculated based on AIBW). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Units
Counts
Participants
OG00043
OG00124
OG002113
OG00324
Title
Denominators
Categories
Title
Measurements
OG0002.6(1.3 to 3.3)
OG0013.9(1.8 to 11.1)
OG0024.3(3.9 to 5.4)
OG0032.8(1.2 to 4.2)
OG001
Dose Escalation: Schedule B (Mirvetuximab Soravtansine Weekly)
Participants received mirvetuximab soravtansine IV infusion on Days 1, 8, and 15 of every 28-day cycle. Dose escalation started at 1.1 mg/kg and proceeded through 2.5 mg/kg (calculated based on AIBW). The doses evaluated during dose escalation for Schedule B, AIBW were: 1.1 mg/kg (n=5); 1.8 mg/kg (n=4), 2.0 mg/kg (n=9); and 2.5 mg/kg (n=7). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with EOC received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle (calculated based on AIBW). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with EC received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle (calculated based on AIBW). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Units
Counts
Participants
OG00043
OG00124
OG002113
OG00324
Title
Denominators
Categories
Title
Measurements
OG0002.7(1.3 to 3.3)
OG0013.9(1.8 to 11.1)
OG0024.4(4.0 to 5.6)
OG0032.8(1.2 to 6.9)
OG002
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 1.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG003
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG004
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W)
Participants received mirvetuximab soravtansine 3.3 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG005
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 5.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG006
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 6.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG007
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 7.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG008
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly)
Participants received mirvetuximab soravtansine 1.1 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG009
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly)
Participants received mirvetuximab soravtansine 1.8 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG010
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly)
Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG011
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly)
Participants received mirvetuximab soravtansine 2.5 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with EOC, primary peritoneal cancer, or fallopian tube cancer resistant to platinum-based therapy received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with FOLR1-positive uterine cancer (that was advanced or recurrent and had received at least 1 platinum-based regimen, and no more than 5 prior systemic treatment regimens for EC) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with biopsy-accessible relapsed or refractory ovarian cancer, primary peritoneal cancer, or fallopian tube cancer received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with EOC primary peritoneal cancer or fallopian tube cancer (that had relapsed following platinum-based therapy, excluding those participants with primary platinum refractory disease or low grade or clear cell ovarian cancer) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Units
Counts
Participants
OG0002
OG0011
OG0021
OG0031
OG0049
OG00518
OG0067
OG0075
OG0085
OG0094
OG0109
OG0117
OG01246
OG01324
OG01427
OG01540
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0041
OG0051
OG0060
OG0070
OG0080
OG0090
OG0101
OG0110
OG0120
OG0137
OG0142
OG0152
OG002
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 1.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG003
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG004
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W)
Participants received mirvetuximab soravtansine 3.3 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG005
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 5.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG006
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 6.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG007
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 7.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG008
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly)
Participants received mirvetuximab soravtansine 1.1 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG009
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly)
Participants received mirvetuximab soravtansine 1.8 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG010
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly)
Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
OG011
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly)
Participants received mirvetuximab soravtansine 2.5 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with EOC, primary peritoneal cancer, or fallopian tube cancer resistant to platinum-based therapy received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with FOLR1-positive uterine cancer (that was advanced or recurrent and had received at least 1 platinum-based regimen, and no more than 5 prior systemic treatment regimens for EC) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with biopsy-accessible relapsed or refractory ovarian cancer, primary peritoneal cancer, or fallopian tube cancer received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with EOC primary peritoneal cancer or fallopian tube cancer (that had relapsed following platinum-based therapy, excluding those participants with primary platinum refractory disease or low grade or clear cell ovarian cancer) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.