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A Study of Mirvetuximab Soravtansine vs. Investigator's Choice of Chemotherapy in Women With Folate Receptor (FR) Alpha Positive Advanced Epithelial Ovarian Cancer (EOC), Primary Peritoneal or Fallopian Tube Cancer (FORWARD I)

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ClinicalTrials.gov Identifier: NCT02631876
Recruitment Status : Completed
First Posted : December 16, 2015
Results First Posted : June 9, 2020
Last Update Posted : October 14, 2020
Sponsor:
Collaborator:
Gynecologic Oncology Group
Information provided by (Responsible Party):
ImmunoGen, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Epithelial Ovarian Cancer
Primary Peritoneal Carcinoma
Fallopian Tube Cancer
Ovarian Cancer
Interventions Drug: Mirvetuximab soravtansine
Drug: Paclitaxel
Drug: Pegylated liposomal doxorubicin
Drug: Topotecan
Enrollment 366
Recruitment Details  
Pre-assignment Details A total of 366 participants were randomized in 2:1 to receive either mirvetuximab soravtansine or the investigator's choice (IC) chemotherapy.
Arm/Group Title Mirvetuximab Soravtansine Investigator's Choice (IC) Chemotherapy
Hide Arm/Group Description Participants received mirvetuximab soravtansine at 6 milligrams/kilogram (mg/kg) adjusted ideal body weight (AIBW) administered intravenously (IV) on Day 1 of a 3 week cycle. Participants continued to receive study drug until they experienced progressive disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (as assessed by the blinded independent review committee [BIRC]), experienced unacceptable toxicity, or withdrew consent, whichever came first, or until the sponsor terminated the study. (Maximum exposure: 86.9 weeks) Participants received a dose of IC chemotherapeutic agent calculated using body surface area (BSA). Paclitaxel administered at 80 milligrams/square meter (mg/m^2) as a 1-hour IV infusion on Days 1, 8, 15, and 22 of a 4-week cycle; or topotecan administered at 4 mg/m^2 over 30 minutes on Days 1, 8, and 15 of a 4-week cycle. Alternatively, topotecan could have been administered at 1.25 mg/m^2 over 30 minutes on Days 1 to 5 of a 3-week cycle; or pegylated liposomal doxorubicin administered at 40 mg/m^2 as a 1 mg/minute IV infusion on Day 1 of a 4-week cycle. After Cycle 1, if tolerated, pegylated liposomal doxorubicin could have been administered as a 1-hour infusion. Participants continued to receive study drug until they experienced PD per RECIST version 1.1 (as assessed by BIRC), experienced unacceptable toxicity, or withdrew consent, whichever came first, or until the sponsor terminated the study. (Maximum exposure: 62.9 weeks)
Period Title: Overall Study
Started [1] 248 118
Safety Population [2] 243 109
Completed 129 55
Not Completed 119 63
Reason Not Completed
Death             96             50
Investigator's discretion             1             0
Lost to Follow-up             2             0
Withdrawal by Subject             16             9
Other than specified             4             4
[1]
ITT population: all participants randomized in the study.
[2]
Enrolled participants who received at least 1 dose of mirvetuximab soravtansine or IC chemotherapy.
Arm/Group Title Mirvetuximab Soravtansine Investigator's Choice (IC) Chemotherapy Total
Hide Arm/Group Description Participants received mirvetuximab soravtansine at 6 mg/kg AIBW administered IV on Day 1 of a 3 week cycle. Participants continued to receive study drug until they experienced PD per RECIST version 1.1 (as assessed by BIRC), experienced unacceptable toxicity, or withdrew consent, whichever came first, or until the sponsor terminated the study. (Maximum exposure: 86.9 weeks) Participants received a dose of IC chemotherapeutic agent calculated using BSA. Paclitaxel administered at 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 of a 4-week cycle; or topotecan administered at 4 mg/m^2 over 30 minutes on Days 1, 8, and 15 of a 4-week cycle. Alternatively, topotecan could have been administered at 1.25 mg/m^2 over 30 minutes on Days 1 to 5 of a 3-week cycle; or pegylated liposomal doxorubicin administered at 40 mg/m^2 as a 1 mg/minute IV infusion on Day 1 of a 4-week cycle. After Cycle 1, if tolerated, pegylated liposomal doxorubicin could have been administered as a 1-hour infusion. Participants continued to receive study drug until they experienced PD per RECIST version 1.1 (as assessed by BIRC), experienced unacceptable toxicity, or withdrew consent, whichever came first, or until the sponsor terminated the study. (Maximum exposure: 62.9 weeks) Total of all reporting groups
Overall Number of Baseline Participants 248 118 366
Hide Baseline Analysis Population Description
ITT population included all participants randomized in the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 248 participants 118 participants 366 participants
62.7  (10.29) 62.9  (10.51) 62.8  (10.35)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 248 participants 118 participants 366 participants
Female
248
 100.0%
118
 100.0%
366
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 248 participants 118 participants 366 participants
Hispanic or Latino
12
   4.8%
9
   7.6%
21
   5.7%
Not Hispanic or Latino
225
  90.7%
102
  86.4%
327
  89.3%
Unknown or Not Reported
11
   4.4%
7
   5.9%
18
   4.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 248 participants 118 participants 366 participants
American Indian or Alaska Native
0
   0.0%
1
   0.8%
1
   0.3%
Asian
6
   2.4%
2
   1.7%
8
   2.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
7
   2.8%
3
   2.5%
10
   2.7%
White
225
  90.7%
105
  89.0%
330
  90.2%
More than one race
2
   0.8%
2
   1.7%
4
   1.1%
Unknown or Not Reported
8
   3.2%
5
   4.2%
13
   3.6%
1.Primary Outcome
Title Progression-Free Survival (PFS), as Assessed by BIRC Per RECIST Version 1.1 in All Participants Randomized to the Study
Hide Description PFS was defined as the time from randomization until PD or death whichever occurred first, estimated using the Kaplan-Meier method. PD: At least a 20% increase in the sum of the longest diameters (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.
Time Frame From the date of randomization until the time of death or PD (maximum exposure: 86.9 weeks for mirvetuximab soravtansine arm and 62.9 weeks for IC chemotherapy arm)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants randomized in the study.
Arm/Group Title Mirvetuximab Soravtansine Investigator's Choice (IC) Chemotherapy
Hide Arm/Group Description:
Participants received mirvetuximab soravtansine at 6 mg/kg AIBW administered IV on Day 1 of a 3 week cycle. Participants continued to receive study drug until they experienced PD per RECIST version 1.1 (as assessed by BIRC), experienced unacceptable toxicity, or withdrew consent, whichever came first, or until the sponsor terminated the study. (Maximum exposure: 86.9 weeks)
Participants received a dose of IC chemotherapeutic agent calculated using BSA. Paclitaxel administered at 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 of a 4-week cycle; or topotecan administered at 4 mg/m^2 over 30 minutes on Days 1, 8, and 15 of a 4-week cycle. Alternatively, topotecan could have been administered at 1.25 mg/m^2 over 30 minutes on Days 1 to 5 of a 3-week cycle; or pegylated liposomal doxorubicin administered at 40 mg/m^2 as a 1 mg/minute IV infusion on Day 1 of a 4-week cycle. After Cycle 1, if tolerated, pegylated liposomal doxorubicin could have been administered as a 1-hour infusion. Participants continued to receive study drug until they experienced PD per RECIST version 1.1 (as assessed by BIRC), experienced unacceptable toxicity, or withdrew consent, whichever came first, or until the sponsor terminated the study. (Maximum exposure: 62.9 weeks)
Overall Number of Participants Analyzed 248 118
Median (95% Confidence Interval)
Unit of Measure: months
4.14
(3.75 to 4.53)
4.44
(2.83 to 5.59)
2.Primary Outcome
Title PFS, as Assessed by BIRC Per RECIST Version 1.1 in Participants With High Folate Receptor Alpha Level (≥ 75% of Tumor Staining)
Hide Description PFS was defined as the time from randomization 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.
Time Frame From the date of randomization until the time of death or PD (maximum exposure: 86.9 weeks for mirvetuximab soravtansine arm and 62.9 weeks for IC chemotherapy arm)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants randomized in the study. Here, overall number of participants analyzed signifies participants with high folate receptor alpha level.
Arm/Group Title Mirvetuximab Soravtansine Investigator's Choice (IC) Chemotherapy
Hide Arm/Group Description:
Participants received mirvetuximab soravtansine at 6 mg/kg AIBW administered IV on Day 1 of a 3 week cycle. Participants continued to receive study drug until they experienced PD per RECIST version 1.1 (as assessed by BIRC), experienced unacceptable toxicity, or withdrew consent, whichever came first, or until the sponsor terminated the study. (Maximum exposure: 86.9 weeks)
Participants received a dose of IC chemotherapeutic agent calculated using BSA. Paclitaxel administered at 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 of a 4-week cycle; or topotecan administered at 4 mg/m^2 over 30 minutes on Days 1, 8, and 15 of a 4-week cycle. Alternatively, topotecan could have been administered at 1.25 mg/m^2 over 30 minutes on Days 1 to 5 of a 3-week cycle; or pegylated liposomal doxorubicin administered at 40 mg/m^2 as a 1 mg/minute IV infusion on Day 1 of a 4-week cycle. After Cycle 1, if tolerated, pegylated liposomal doxorubicin could have been administered as a 1-hour infusion. Participants continued to receive study drug until they experienced PD per RECIST version 1.1 (as assessed by BIRC), experienced unacceptable toxicity, or withdrew consent, whichever came first, or until the sponsor terminated the study. (Maximum exposure: 62.9 weeks)
Overall Number of Participants Analyzed 147 71
Median (95% Confidence Interval)
Unit of Measure: months
4.76
(4.11 to 5.68)
3.25
(1.97 to 5.59)
3.Secondary Outcome
Title Objective Response Rate (ORR): Percentage of Participants With Objective Response, as Assessed by BIRC Per RECIST1.1
Hide Description 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 SoD of target lesions, taking as reference the baseline SoD.
Time Frame From randomization until first BOR of CR or PR (maximum exposure: 86.9 weeks for mirvetuximab soravtansine arm and 62.9 weeks for IC chemotherapy arm)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants randomized in the study.
Arm/Group Title Mirvetuximab Soravtansine Investigator's Choice (IC) Chemotherapy
Hide Arm/Group Description:
Participants received mirvetuximab soravtansine at 6 mg/kg AIBW administered IV on Day 1 of a 3 week cycle. Participants continued to receive study drug until they experienced PD per RECIST version 1.1 (as assessed by BIRC), experienced unacceptable toxicity, or withdrew consent, whichever came first, or until the sponsor terminated the study. (Maximum exposure: 86.9 weeks)
Participants received a dose of IC chemotherapeutic agent calculated using BSA. Paclitaxel administered at 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 of a 4-week cycle; or topotecan administered at 4 mg/m^2 over 30 minutes on Days 1, 8, and 15 of a 4-week cycle. Alternatively, topotecan could have been administered at 1.25 mg/m^2 over 30 minutes on Days 1 to 5 of a 3-week cycle; or pegylated liposomal doxorubicin administered at 40 mg/m^2 as a 1 mg/minute IV infusion on Day 1 of a 4-week cycle. After Cycle 1, if tolerated, pegylated liposomal doxorubicin could have been administered as a 1-hour infusion. Participants continued to receive study drug until they experienced PD per RECIST version 1.1 (as assessed by BIRC), experienced unacceptable toxicity, or withdrew consent, whichever came first, or until the sponsor terminated the study. (Maximum exposure: 62.9 weeks)
Overall Number of Participants Analyzed 248 118
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
22
(17.2 to 27.9)
12
(6.6 to 19.1)
4.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was defined as the time from the date of randomization until the date of death from any cause. Participants who did not experience the event of death were censored at their last date known to be alive. OS was estimated using the Kaplan-Meier method.
Time Frame From the date of randomization until the time of death (maximum exposure: 86.9 weeks for mirvetuximab soravtansine arm and 62.9 weeks for IC chemotherapy arm)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants randomized in the study.
Arm/Group Title Mirvetuximab Soravtansine Investigator's Choice (IC) Chemotherapy
Hide Arm/Group Description:
Participants received mirvetuximab soravtansine at 6 mg/kg AIBW administered IV on Day 1 of a 3 week cycle. Participants continued to receive study drug until they experienced PD per RECIST version 1.1 (as assessed by BIRC), experienced unacceptable toxicity, or withdrew consent, whichever came first, or until the sponsor terminated the study. (Maximum exposure: 86.9 weeks)
Participants received a dose of IC chemotherapeutic agent calculated using BSA. Paclitaxel administered at 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 of a 4-week cycle; or topotecan administered at 4 mg/m^2 over 30 minutes on Days 1, 8, and 15 of a 4-week cycle. Alternatively, topotecan could have been administered at 1.25 mg/m^2 over 30 minutes on Days 1 to 5 of a 3-week cycle; or pegylated liposomal doxorubicin administered at 40 mg/m^2 as a 1 mg/minute IV infusion on Day 1 of a 4-week cycle. After Cycle 1, if tolerated, pegylated liposomal doxorubicin could have been administered as a 1-hour infusion. Participants continued to receive study drug until they experienced PD per RECIST version 1.1 (as assessed by BIRC), experienced unacceptable toxicity, or withdrew consent, whichever came first, or until the sponsor terminated the study. (Maximum exposure: 62.9 weeks)
Overall Number of Participants Analyzed 248 118
Median (95% Confidence Interval)
Unit of Measure: months
15.57
(12.85 to 18.04)
13.93
(11.40 to 18.50)
5.Secondary Outcome
Title Number of Participants Achieving at Least a 15% (≥ 15-Point) Absolute Improvement From Baseline on the EORTC QLQ-OV28 Abdominal/Gastrointestinal (AB/GI) Symptom Subscale at Week 8/9 Assessment
Hide Description European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Ovarian Cancer 28 (EORTC QLQ-OV28) is a 28-item ovarian cancer supplemental module. It comprises of 6 symptom scales (AB/GI symptoms, peripheral neuropathy, other chemotherapy side-effects, hormonal symptoms, body image, attitude to disease, treatment), and sexual functioning. Participants were asked to indicate extent to which they experienced AB/GI symptoms. Participants responded on a scale of 1-4(1=not at all, 2=a little, 3=quite a bit, 4=very much) to following: Did you have abdominal pain? Did you have a bloated feeling in your abdomen? Did you have problems with your clothes feeling too tight? Did you experience any change in bowel habit as a result of your disease or treatment? Were you troubled by passing wind/gas/flatulence? Have you felt full too quickly after beginning to eat? Have you had indigestion/heartburn? Data were transformed to a scale from 0-100. Lower scores=better health.
Time Frame Baseline, Week 8/9
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants randomized in the study. Here, 'overall number of participants analyzed' signifies participants evaluable for this outcome measure.
Arm/Group Title Mirvetuximab Soravtansine Investigator's Choice (IC) Chemotherapy
Hide Arm/Group Description:
Participants received mirvetuximab soravtansine at 6 mg/kg AIBW administered IV on Day 1 of a 3 week cycle. Participants continued to receive study drug until they experienced PD per RECIST version 1.1 (as assessed by BIRC), experienced unacceptable toxicity, or withdrew consent, whichever came first, or until the sponsor terminated the study. (Maximum exposure: 86.9 weeks)
Participants received a dose of IC chemotherapeutic agent calculated using BSA. Paclitaxel administered at 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 of a 4-week cycle; or topotecan administered at 4 mg/m^2 over 30 minutes on Days 1, 8, and 15 of a 4-week cycle. Alternatively, topotecan could have been administered at 1.25 mg/m^2 over 30 minutes on Days 1 to 5 of a 3-week cycle; or pegylated liposomal doxorubicin administered at 40 mg/m^2 as a 1 mg/minute IV infusion on Day 1 of a 4-week cycle. After Cycle 1, if tolerated, pegylated liposomal doxorubicin could have been administered as a 1-hour infusion. Participants continued to receive study drug until they experienced PD per RECIST version 1.1 (as assessed by BIRC), experienced unacceptable toxicity, or withdrew consent, whichever came first, or until the sponsor terminated the study. (Maximum exposure: 62.9 weeks)
Overall Number of Participants Analyzed 142 50
Measure Type: Count of Participants
Unit of Measure: Participants
45
  31.7%
7
  14.0%
6.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Hide Description Adverse event (AE): 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: graded per National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) v4.03 on following scale: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening, Grade 5=death. Relation of AE to treatment was determined by investigator. Serious AEs: death, life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent/significant disability or incapacity, congenital anomaly or birth defect, or an important medical event that required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs: any AE that emerged on or after the first dose, and within 30 days of the last dose. A summary of serious and all other non-serious AEs regardless of causality is located in the Reported AEs module.
Time Frame From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 86.9 weeks for mirvetuximab soravtansine arm and 62.9 weeks for IC chemotherapy arm)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all enrolled participants who received at least 1 dose of mirvetuximab soravtansine or IC chemotherapy.
Arm/Group Title Mirvetuximab Soravtansine Investigator's Choice (IC) Chemotherapy
Hide Arm/Group Description:
Participants received mirvetuximab soravtansine at 6 mg/kg AIBW administered IV on Day 1 of a 3 week cycle. Participants continued to receive study drug until they experienced PD per RECIST version 1.1 (as assessed by BIRC), experienced unacceptable toxicity, or withdrew consent, whichever came first, or until the sponsor terminated the study. (Maximum exposure: 86.9 weeks)
Participants received a dose of IC chemotherapeutic agent calculated using BSA. Paclitaxel administered at 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 of a 4-week cycle; or topotecan administered at 4 mg/m^2 over 30 minutes on Days 1, 8, and 15 of a 4-week cycle. Alternatively, topotecan could have been administered at 1.25 mg/m^2 over 30 minutes on Days 1 to 5 of a 3-week cycle; or pegylated liposomal doxorubicin administered at 40 mg/m^2 as a 1 mg/minute IV infusion on Day 1 of a 4-week cycle. After Cycle 1, if tolerated, pegylated liposomal doxorubicin could have been administered as a 1-hour infusion. Participants continued to receive study drug until they experienced PD per RECIST version 1.1 (as assessed by BIRC), experienced unacceptable toxicity, or withdrew consent, whichever came first, or until the sponsor terminated the study. (Maximum exposure: 62.9 weeks)
Overall Number of Participants Analyzed 243 109
Measure Type: Count of Participants
Unit of Measure: Participants
242
  99.6%
107
  98.2%
7.Secondary Outcome
Title Gynecologic Cancer Intergroup (GCIG) CA-125 Response Rate: Percentage of Participants With GCIG CA-125 Confirmed Clinical Responses
Hide Description CA-125 Response rate wasdefined as the number of participants with a CA-125 confirmed response divided by the number of participants in the CA-125 response-evaluable population multiplied by 100.
Time Frame From first dose of study drug until CA-125 response (maximum exposure: 86.9 weeks for mirvetuximab soravtansine arm and 62.9 weeks for IC chemotherapy arm)
Hide Outcome Measure Data
Hide Analysis Population Description
CA-125-Evaluable population included all randomized population whose pretreatment sample was ≥ 2.0 times the upper limit of normal (ULN), within 2 weeks prior to randomization, and who had at least 1 post-baseline CA 125 evaluation.
Arm/Group Title Mirvetuximab Soravtansine Investigator's Choice (IC) Chemotherapy
Hide Arm/Group Description:
Participants received MIRV mirvetuximab soravtansine at 6 mg/kg AIBW administered IV on Day 1 of a 3 week cycle. Participants continued to receive study drug until they experienced PD per RECIST version 1.1 (as assessed by BIRC), experienced unacceptable toxicity, or withdrew consent, whichever came first, or until the sponsor terminated the study. (Maximum exposure: 86.9 weeks)
Participants received a dose of IC chemotherapeutic agent calculated using BSA. Paclitaxel administered at 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 of a 4-week cycle; or topotecan administered at 4 mg/m^2 over 30 minutes on Days 1, 8, and 15 of a 4-week cycle. Alternatively, topotecan could have been administered at 1.25 mg/m^2 over 30 minutes on Days 1 to 5 of a 3-week cycle; or pegylated liposomal doxorubicin administered at 40 mg/m^2 as a 1 mg/minute IV infusion on Day 1 of a 4-week cycle. After Cycle 1, if tolerated, pegylated liposomal doxorubicin could have been administered as a 1-hour infusion. Participants continued to receive study drug until they experienced PD per RECIST version 1.1 (as assessed by BIRC), experienced unacceptable toxicity, or withdrew consent, whichever came first, or until the sponsor terminated the study. (Maximum exposure: 62.9 weeks)
Overall Number of Participants Analyzed 203 82
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
51
(44.1 to 58.3)
27
(17.6 to 37.8)
8.Secondary Outcome
Title PFS, as Assessed by Investigator Per RECIST Version 1.1
Hide Description PFS was defined as the time from randomization 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.
Time Frame From the date of randomization until the time of death or PD (maximum exposure: 86.9 weeks for mirvetuximab soravtansine arm and 62.9 weeks for IC chemotherapy arm)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants randomized in the study.
Arm/Group Title Mirvetuximab Soravtansine Investigator's Choice (IC) Chemotherapy
Hide Arm/Group Description:
Participants received mirvetuximab soravtansine at 6 mg/kg AIBW administered IV on Day 1 of a 3 week cycle. Participants continued to receive study drug until they experienced PD per RECIST version 1.1 (as assessed by BIRC), experienced unacceptable toxicity, or withdrew consent, whichever came first, or until the sponsor terminated the study. (Maximum exposure: 86.9 weeks)
Participants received a dose of IC chemotherapeutic agent calculated using BSA. Paclitaxel administered at 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 of a 4-week cycle; or topotecan administered at 4 mg/m^2 over 30 minutes on Days 1, 8, and 15 of a 4-week cycle. Alternatively, topotecan could have been administered at 1.25 mg/m^2 over 30 minutes on Days 1 to 5 of a 3-week cycle; or pegylated liposomal doxorubicin administered at 40 mg/m^2 as a 1 mg/minute IV infusion on Day 1 of a 4-week cycle. After Cycle 1, if tolerated, pegylated liposomal doxorubicin could have been administered as a 1-hour infusion. Participants continued to receive study drug until they experienced PD per RECIST version 1.1 (as assessed by BIRC), experienced unacceptable toxicity, or withdrew consent, whichever came first, or until the sponsor terminated the study. (Maximum exposure: 62.9 weeks)
Overall Number of Participants Analyzed 248 118
Median (95% Confidence Interval)
Unit of Measure: months
4.27
(4.11 to 5.06)
4.24
(2.76 to 5.36)
9.Secondary Outcome
Title Duration of Response (DOR), as Assessed by BIRC Per RECIST v1.1
Hide Description DOR was defined as the time from the date of the first response (CR or PR), whichever was recorded first, until the date of 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.
Time Frame From the date of first response (CR or PR) until the date of PD (maximum exposure: 86.9 weeks for mirvetuximab soravtansine arm and 62.9 weeks for IC chemotherapy arm)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants randomized in the study. Here, 'overall number of participants analyzed' signifies participants evaluable for this outcome measure.
Arm/Group Title Mirvetuximab Soravtansine Investigator's Choice (IC) Chemotherapy
Hide Arm/Group Description:
Participants received mirvetuximab soravtansine at 6 mg/kg AIBW administered IV on Day 1 of a 3 week cycle. Participants continued to receive study drug until they experienced PD per RECIST version 1.1 (as assessed by BIRC), experienced unacceptable toxicity, or withdrew consent, whichever came first, or until the sponsor terminated the study. (Maximum exposure: 86.9 weeks)
Participants received a dose of IC chemotherapeutic agent calculated using BSA. Paclitaxel administered at 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 of a 4-week cycle; or topotecan administered at 4 mg/m^2 over 30 minutes on Days 1, 8, and 15 of a 4-week cycle. Alternatively, topotecan could have been administered at 1.25 mg/m^2 over 30 minutes on Days 1 to 5 of a 3-week cycle; or pegylated liposomal doxorubicin administered at 40 mg/m^2 as a 1 mg/minute IV infusion on Day 1 of a 4-week cycle. After Cycle 1, if tolerated, pegylated liposomal doxorubicin could have been administered as a 1-hour infusion. Participants continued to receive study drug until they experienced PD per RECIST version 1.1 (as assessed by BIRC), experienced unacceptable toxicity, or withdrew consent, whichever came first, or until the sponsor terminated the study. (Maximum exposure: 62.9 weeks)
Overall Number of Participants Analyzed 55 14
Median (95% Confidence Interval)
Unit of Measure: months
5.65
(4.17 to 8.51)
7.26 [1] 
(4.14 to NA)
[1]
Data not calculated due to less number of participants with an event
10.Secondary Outcome
Title Area Under the Plasma Concentration-Versus Time Curve From Time of Dose Until Tlast (AUClast) of Mirvetuximab Soravtansine,Total M9346A Antibody, DM4, and S-methyl DM4
Hide Description PK parameters were calculated using standard non-compartmental methods.
Time Frame Pre-dose and within 5 minutes after mirvetuximab soravtansine infusion on Day 1 of Cycles 1 and 3; and Day 8 and 15 of Cycles 1 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
PK population included all participants who received at least 1 infusion of mirvetuximab soravtansine, had evaluable PK data, and had samples collected with no major deviations related to administration of study drug. Here, 'number analyzed'=participants evaluable for specified categories.
Arm/Group Title Mirvetuximab Soravtansine
Hide Arm/Group Description:
Participants received mirvetuximab soravtansine at 6 mg/kg AIBW administered IV on Day 1 of a 3 week cycle. Participants continued to receive study drug until they experienced PD per RECIST version 1.1 (as assessed by BIRC), experienced unacceptable toxicity, or withdrew consent, whichever came first, or until the sponsor terminated the study. (Maximum exposure: 86.9 weeks)
Overall Number of Participants Analyzed 235
Mean (Standard Deviation)
Unit of Measure: hours*milligrams/milliliter (hr*mg/mL)
Mirvetuximab Soravtansine at Cycle 1 Number Analyzed 235 participants
20.53  (10.31)
Mirvetuximab Soravtansine at Cycle 3 Number Analyzed 146 participants
22.40  (7.770)
Total M9346A antibody at Cycle 1 Number Analyzed 235 participants
23.23  (9.463)
Total M9346A antibody at Cycle 3 Number Analyzed 146 participants
31.20  (11.52)
DM4 at Cycle 1 Number Analyzed 233 participants
348.5  (265.7)
DM4 at Cycle 3 Number Analyzed 142 participants
347.4  (280.9)
S-methyl DM4 at Cycle 1 Number Analyzed 234 participants
1586  (1496)
S-methyl DM4 at Cycle 3 Number Analyzed 146 participants
1512  (1278)
11.Secondary Outcome
Title Number of Participants With Anti-Drug Antibodies (ADA)
Hide Description An electrochemiluminescent method was used for the detection of anti-mirvetuximab soravtansine antibodies in plasma from samples collected in dipotassium ethylenediaminetetraacetic acid (K2EDTA) tubes. The qualitative assay was designed to detect anti-mirvetuximab soravtansine antibodies in human plasma.
Time Frame Pre-dose and within 5 minutes after mirvetuximab soravtansine infusion on Day 1 of Cycles 1, 2, and 4; pre-dose on Day 1 of Cycle 6
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Hide Analysis Population Description
Immunogenicity population included all participants who received at least 1 infusion of mirvetuximab soravtansine and had evaluable immunogenicity data.
Arm/Group Title Mirvetuximab Soravtansine
Hide Arm/Group Description:
Participants received mirvetuximab soravtansine at 6 mg/kg AIBW administered IV on Day 1 of a 3 week cycle. Participants continued to receive study drug until they experienced PD per RECIST version 1.1 (as assessed by BIRC), experienced unacceptable toxicity, or withdrew consent, whichever came first, or until the sponsor terminated the study. (Maximum exposure: 86.9 weeks)
Overall Number of Participants Analyzed 230
Measure Type: Count of Participants
Unit of Measure: Participants
13
   5.7%
Time Frame From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 86.9 weeks for mirvetuximab soravtansine arm and 62.9 weeks for IC chemotherapy arm)
Adverse Event Reporting Description Safety population included all enrolled participants who received at least 1 dose of mirvetuximab soravtansine or IC chemotherapy.
 
Arm/Group Title Mirvetuximab Soravtansine Investigator's Choice (IC) Chemotherapy
Hide Arm/Group Description Participants received mirvetuximab soravtansine at 6 mg/kg AIBW administered IV on Day 1 of a 3 week cycle. Participants continued to receive study drug until they experienced PD per RECIST version 1.1 (as assessed by BIRC), experienced unacceptable toxicity, or withdrew consent, whichever came first, or until the sponsor terminated the study. (Maximum exposure: 86.9 weeks) Participants received a dose of IC chemotherapeutic agent calculated using BSA. Paclitaxel administered at 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 of a 4-week cycle; or topotecan administered at 4 mg/m^2 over 30 minutes on Days 1, 8, and 15 of a 4-week cycle. Alternatively, topotecan could have been administered at 1.25 mg/m^2 over 30 minutes on Days 1 to 5 of a 3-week cycle; or pegylated liposomal doxorubicin administered at 40 mg/m^2 as a 1 mg/minute IV infusion on Day 1 of a 4-week cycle. After Cycle 1, if tolerated, pegylated liposomal doxorubicin could have been administered as a 1-hour infusion. Participants continued to receive study drug until they experienced PD per RECIST version 1.1 (as assessed by BIRC), experienced unacceptable toxicity, or withdrew consent, whichever came first, or until the sponsor terminated the study. (Maximum exposure: 62.9 weeks)
All-Cause Mortality
Mirvetuximab Soravtansine Investigator's Choice (IC) Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   96/243 (39.51%)   50/109 (45.87%) 
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Mirvetuximab Soravtansine Investigator's Choice (IC) Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   67/243 (27.57%)   31/109 (28.44%) 
Blood and lymphatic system disorders     
Anaemia  1  0/243 (0.00%)  1/109 (0.92%) 
Febrile neutropenia  1  0/243 (0.00%)  1/109 (0.92%) 
Cardiac disorders     
Cardiac arrest  1  2/243 (0.82%)  0/109 (0.00%) 
Eye disorders     
Eye pain  1  1/243 (0.41%)  0/109 (0.00%) 
Punctate keratitis  1  1/243 (0.41%)  0/109 (0.00%) 
Gastrointestinal disorders     
Intestinal obstruction  1  10/243 (4.12%)  3/109 (2.75%) 
Small intestinal obstruction  1  5/243 (2.06%)  4/109 (3.67%) 
Constipation  1  4/243 (1.65%)  1/109 (0.92%) 
Large intestinal obstruction  1  4/243 (1.65%)  2/109 (1.83%) 
Abdominal pain  1  2/243 (0.82%)  2/109 (1.83%) 
Nausea  1  2/243 (0.82%)  1/109 (0.92%) 
Vomiting  1  2/243 (0.82%)  2/109 (1.83%) 
Abdominal incarcerated hernia  1  1/243 (0.41%)  0/109 (0.00%) 
Abdominal pain upper  1  1/243 (0.41%)  0/109 (0.00%) 
Ascites  1  1/243 (0.41%)  2/109 (1.83%) 
Gastritis  1  1/243 (0.41%)  0/109 (0.00%) 
Intestinal perforation  1  1/243 (0.41%)  0/109 (0.00%) 
General disorders     
Asthenia  1  1/243 (0.41%)  0/109 (0.00%) 
Complication associated with device  1  1/243 (0.41%)  0/109 (0.00%) 
Systemic inflammatory response syndrome  1  1/243 (0.41%)  1/109 (0.92%) 
Fatigue  1  0/243 (0.00%)  1/109 (0.92%) 
General physical health deterioration  1  0/243 (0.00%)  1/109 (0.92%) 
Pyrexia  1  0/243 (0.00%)  3/109 (2.75%) 
Hepatobiliary disorders     
Cholecystitis acute  1  0/243 (0.00%)  1/109 (0.92%) 
Infections and infestations     
Sepsis  1  3/243 (1.23%)  3/109 (2.75%) 
Urinary tract infection  1  2/243 (0.82%)  1/109 (0.92%) 
Campylobacter gastroenteritis  1  1/243 (0.41%)  0/109 (0.00%) 
Gastroenteritis viral  1  1/243 (0.41%)  0/109 (0.00%) 
Influenza  1  1/243 (0.41%)  0/109 (0.00%) 
Oesophageal infection  1  1/243 (0.41%)  0/109 (0.00%) 
Pyelonephritis  1  1/243 (0.41%)  0/109 (0.00%) 
Systemic infection  1  1/243 (0.41%)  0/109 (0.00%) 
Upper respiratory tract infection  1  1/243 (0.41%)  0/109 (0.00%) 
Urosepsis  1  1/243 (0.41%)  1/109 (0.92%) 
Vestibular neuronitis  1  1/243 (0.41%)  0/109 (0.00%) 
Salmonellosis  1  0/243 (0.00%)  1/109 (0.92%) 
Injury, poisoning and procedural complications     
Acetabulum fracture  1  1/243 (0.41%)  0/109 (0.00%) 
Facial bones fracture  1  1/243 (0.41%)  0/109 (0.00%) 
Infusion related reaction  1  1/243 (0.41%)  0/109 (0.00%) 
Lumbar vertebral fracture  1  1/243 (0.41%)  0/109 (0.00%) 
Rib fracture  1  1/243 (0.41%)  0/109 (0.00%) 
Subdural haematoma  1  1/243 (0.41%)  0/109 (0.00%) 
Hip fracture  1  0/243 (0.00%)  1/109 (0.92%) 
Metabolism and nutrition disorders     
Dehydration  1  4/243 (1.65%)  0/109 (0.00%) 
Failure to thrive  1  1/243 (0.41%)  0/109 (0.00%) 
Hypocalcaemia  1  1/243 (0.41%)  0/109 (0.00%) 
Hypokalaemia  1  1/243 (0.41%)  0/109 (0.00%) 
Hyponatraemia  1  1/243 (0.41%)  0/109 (0.00%) 
Decreased appetite  1  0/243 (0.00%)  1/109 (0.92%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Malignant pleural effusion  1  1/243 (0.41%)  0/109 (0.00%) 
Tumour obstruction  1  1/243 (0.41%)  0/109 (0.00%) 
Nervous system disorders     
Syncope  1  2/243 (0.82%)  0/109 (0.00%) 
Headache  1  1/243 (0.41%)  0/109 (0.00%) 
Presyncope  1  1/243 (0.41%)  0/109 (0.00%) 
Cerebrovascular accident  1  0/243 (0.00%)  1/109 (0.92%) 
Psychiatric disorders     
Mania  1  0/243 (0.00%)  1/109 (0.92%) 
Renal and urinary disorders     
Hydronephrosis  1  1/243 (0.41%)  0/109 (0.00%) 
Urinary tract obstruction  1  0/243 (0.00%)  1/109 (0.92%) 
Respiratory, thoracic and mediastinal disorders     
Pneumonitis  1  7/243 (2.88%)  2/109 (1.83%) 
Pleural effusion  1  5/243 (2.06%)  3/109 (2.75%) 
Pulmonary embolism  1  3/243 (1.23%)  0/109 (0.00%) 
Dyspnoea  1  2/243 (0.82%)  2/109 (1.83%) 
Pneumonia aspiration  1  1/243 (0.41%)  0/109 (0.00%) 
Pneumothorax  1  1/243 (0.41%)  0/109 (0.00%) 
Vascular disorders     
Embolism  1  1/243 (0.41%)  0/109 (0.00%) 
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Mirvetuximab Soravtansine Investigator's Choice (IC) Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   242/243 (99.59%)   106/109 (97.25%) 
Blood and lymphatic system disorders     
Anaemia  1  34/243 (13.99%)  32/109 (29.36%) 
Thrombocytopenia  1  27/243 (11.11%)  17/109 (15.60%) 
Neutropenia  1  16/243 (6.58%)  43/109 (39.45%) 
Leukopenia  1  9/243 (3.70%)  16/109 (14.68%) 
Lymphopenia  1  8/243 (3.29%)  3/109 (2.75%) 
Leukocytosis  1  2/243 (0.82%)  0/109 (0.00%) 
Granulomatous lymphadenitis  1  1/243 (0.41%)  0/109 (0.00%) 
Neutrophilia  1  1/243 (0.41%)  0/109 (0.00%) 
Thrombocytosis  1  1/243 (0.41%)  0/109 (0.00%) 
Febrile neutropenia  1  0/243 (0.00%)  1/109 (0.92%) 
Cardiac disorders     
Tachycardia  1  8/243 (3.29%)  2/109 (1.83%) 
Palpitations  1  3/243 (1.23%)  2/109 (1.83%) 
Sinus tachycardia  1  3/243 (1.23%)  2/109 (1.83%) 
Arrhythmia  1  1/243 (0.41%)  0/109 (0.00%) 
Ear and labyrinth disorders     
Tinnitus  1  4/243 (1.65%)  0/109 (0.00%) 
Ear pain  1  2/243 (0.82%)  1/109 (0.92%) 
Vertigo  1  2/243 (0.82%)  2/109 (1.83%) 
Deafness  1  1/243 (0.41%)  0/109 (0.00%) 
Ear discomfort  1  1/243 (0.41%)  1/109 (0.92%) 
Hypoacusis  1  1/243 (0.41%)  0/109 (0.00%) 
Endocrine disorders     
Hyperparathyroidism secondary  1  1/243 (0.41%)  0/109 (0.00%) 
Hypothyroidism  1  1/243 (0.41%)  0/109 (0.00%) 
Eye disorders     
Vision blurred  1  104/243 (42.80%)  6/109 (5.50%) 
Keratopathy  1  77/243 (31.69%)  1/109 (0.92%) 
Dry eye  1  68/243 (27.98%)  2/109 (1.83%) 
Visual acuity reduced  1  52/243 (21.40%)  2/109 (1.83%) 
Cataract  1  36/243 (14.81%)  2/109 (1.83%) 
Photophobia  1  34/243 (13.99%)  2/109 (1.83%) 
Eye pain  1  31/243 (12.76%)  1/109 (0.92%) 
Vitreous floaters  1  13/243 (5.35%)  0/109 (0.00%) 
Foreign body sensation in eyes  1  9/243 (3.70%)  0/109 (0.00%) 
Visual impairment  1  9/243 (3.70%)  1/109 (0.92%) 
Keratitis  1  8/243 (3.29%)  0/109 (0.00%) 
Eye irritation  1  7/243 (2.88%)  0/109 (0.00%) 
Lacrimation increased  1  6/243 (2.47%)  1/109 (0.92%) 
Corneal deposits  1  5/243 (2.06%)  0/109 (0.00%) 
Eye pruritus  1  5/243 (2.06%)  0/109 (0.00%) 
Ocular discomfort  1  5/243 (2.06%)  1/109 (0.92%) 
Punctate keratitis  1  4/243 (1.65%)  0/109 (0.00%) 
Blepharitis  1  3/243 (1.23%)  0/109 (0.00%) 
Diplopia  1  3/243 (1.23%)  0/109 (0.00%) 
Glaucoma  1  3/243 (1.23%)  0/109 (0.00%) 
Photopsia  1  3/243 (1.23%)  0/109 (0.00%) 
Uveitis  1  3/243 (1.23%)  0/109 (0.00%) 
Asthenopia  1  2/243 (0.82%)  0/109 (0.00%) 
Chalazion  1  2/243 (0.82%)  0/109 (0.00%) 
Conjunctival haemorrhage  1  2/243 (0.82%)  0/109 (0.00%) 
Conjunctival hyperaemia  1  2/243 (0.82%)  0/109 (0.00%) 
Lacrimation decreased  1  2/243 (0.82%)  0/109 (0.00%) 
Metamorphopsia  1  2/243 (0.82%)  0/109 (0.00%) 
Ocular hyperaemia  1  2/243 (0.82%)  0/109 (0.00%) 
Xerophthalmia  1  2/243 (0.82%)  0/109 (0.00%) 
Abnormal sensation in eye  1  1/243 (0.41%)  0/109 (0.00%) 
Acquired corneal dystrophy  1  1/243 (0.41%)  0/109 (0.00%) 
Age-related macular degeneration  1  1/243 (0.41%)  0/109 (0.00%) 
Blepharochalasis  1  1/243 (0.41%)  0/109 (0.00%) 
Cataract nuclear  1  1/243 (0.41%)  0/109 (0.00%) 
Conjunctival irritation  1  1/243 (0.41%)  0/109 (0.00%) 
Corneal cyst  1  1/243 (0.41%)  0/109 (0.00%) 
Corneal oedema  1  1/243 (0.41%)  0/109 (0.00%) 
Dyschromatopsia  1  1/243 (0.41%)  0/109 (0.00%) 
Eye disorder  1  1/243 (0.41%)  0/109 (0.00%) 
Eye inflammation  1  1/243 (0.41%)  0/109 (0.00%) 
Eye swelling  1  1/243 (0.41%)  0/109 (0.00%) 
Eyelid oedema  1  1/243 (0.41%)  0/109 (0.00%) 
Eyelid pain  1  1/243 (0.41%)  0/109 (0.00%) 
Eyelid skin dryness  1  1/243 (0.41%)  0/109 (0.00%) 
Halo vision  1  1/243 (0.41%)  0/109 (0.00%) 
Hypermetropia  1  1/243 (0.41%)  0/109 (0.00%) 
Meibomianitis  1  1/243 (0.41%)  0/109 (0.00%) 
Myopia  1  1/243 (0.41%)  0/109 (0.00%) 
Night blindness  1  1/243 (0.41%)  0/109 (0.00%) 
Ocular hypertension  1  1/243 (0.41%)  0/109 (0.00%) 
Ocular toxicity  1  1/243 (0.41%)  0/109 (0.00%) 
Optic nerve disorder  1  1/243 (0.41%)  0/109 (0.00%) 
Papilloedema  1  1/243 (0.41%)  0/109 (0.00%) 
Periorbital oedema  1  1/243 (0.41%)  0/109 (0.00%) 
Pterygium  1  1/243 (0.41%)  0/109 (0.00%) 
Pupils unequal  1  1/243 (0.41%)  0/109 (0.00%) 
Retinal detachment  1  1/243 (0.41%)  0/109 (0.00%) 
Retinal drusen  1  1/243 (0.41%)  0/109 (0.00%) 
Retinopathy  1  1/243 (0.41%)  0/109 (0.00%) 
Sympathetic ophthalmia  1  1/243 (0.41%)  0/109 (0.00%) 
Trichiasis  1  1/243 (0.41%)  0/109 (0.00%) 
Vitreous detachment  1  1/243 (0.41%)  0/109 (0.00%) 
Gastrointestinal disorders     
Nausea  1  131/243 (53.91%)  46/109 (42.20%) 
Diarrhoea  1  107/243 (44.03%)  18/109 (16.51%) 
Abdominal pain  1  80/243 (32.92%)  23/109 (21.10%) 
Constipation  1  64/243 (26.34%)  31/109 (28.44%) 
Vomiting  1  64/243 (26.34%)  22/109 (20.18%) 
Abdominal distension  1  26/243 (10.70%)  11/109 (10.09%) 
Dyspepsia  1  18/243 (7.41%)  5/109 (4.59%) 
Abdominal pain upper  1  15/243 (6.17%)  10/109 (9.17%) 
Gastrooesophageal reflux disease  1  14/243 (5.76%)  5/109 (4.59%) 
Dry mouth  1  11/243 (4.53%)  2/109 (1.83%) 
Abdominal pain lower  1  10/243 (4.12%)  3/109 (2.75%) 
Stomatitis  1  10/243 (4.12%)  23/109 (21.10%) 
Ascites  1  9/243 (3.70%)  6/109 (5.50%) 
Abdominal discomfort  1  8/243 (3.29%)  0/109 (0.00%) 
Flatulence  1  7/243 (2.88%)  1/109 (0.92%) 
Intestinal obstruction  1  4/243 (1.65%)  2/109 (1.83%) 
Aphthous ulcer  1  3/243 (1.23%)  1/109 (0.92%) 
Rectal haemorrhage  1  3/243 (1.23%)  1/109 (0.92%) 
Retching  1  3/243 (1.23%)  0/109 (0.00%) 
Gingival bleeding  1  2/243 (0.82%)  0/109 (0.00%) 
Odynophagia  1  2/243 (0.82%)  1/109 (0.92%) 
Small intestinal obstruction  1  2/243 (0.82%)  1/109 (0.92%) 
Abdominal hernia  1  1/243 (0.41%)  0/109 (0.00%) 
Abdominal tenderness  1  1/243 (0.41%)  1/109 (0.92%) 
Abnormal faeces  1  1/243 (0.41%)  0/109 (0.00%) 
Anal incontinence  1  1/243 (0.41%)  0/109 (0.00%) 
Breath odour  1  1/243 (0.41%)  0/109 (0.00%) 
Coating in mouth  1  1/243 (0.41%)  0/109 (0.00%) 
Colitis  1  1/243 (0.41%)  0/109 (0.00%) 
Dental caries  1  1/243 (0.41%)  2/109 (1.83%) 
Dysphagia  1  1/243 (0.41%)  2/109 (1.83%) 
Enterocolitis haemorrhagic  1  1/243 (0.41%)  0/109 (0.00%) 
Eructation  1  1/243 (0.41%)  0/109 (0.00%) 
Faecal vomiting  1  1/243 (0.41%)  0/109 (0.00%) 
Faeces discoloured  1  1/243 (0.41%)  0/109 (0.00%) 
Faeces soft  1  1/243 (0.41%)  0/109 (0.00%) 
Gastrointestinal motility disorder  1  1/243 (0.41%)  1/109 (0.92%) 
Haematochezia  1  1/243 (0.41%)  0/109 (0.00%) 
Haemorrhoids  1  1/243 (0.41%)  1/109 (0.92%) 
Intestinal perforation  1  1/243 (0.41%)  0/109 (0.00%) 
Large intestinal obstruction  1  1/243 (0.41%)  0/109 (0.00%) 
Mouth cyst  1  1/243 (0.41%)  0/109 (0.00%) 
Mouth ulceration  1  1/243 (0.41%)  1/109 (0.92%) 
Oesophageal pain  1  1/243 (0.41%)  0/109 (0.00%) 
Rectal discharge  1  1/243 (0.41%)  0/109 (0.00%) 
Rectal tenesmus  1  1/243 (0.41%)  0/109 (0.00%) 
Vomiting projectile  1  1/243 (0.41%)  0/109 (0.00%) 
Abdominal mass  1  0/243 (0.00%)  1/109 (0.92%) 
Gastric disorder  1  0/243 (0.00%)  1/109 (0.92%) 
Gastrointestinal obstruction  1  0/243 (0.00%)  1/109 (0.92%) 
Gastrointestinal pain  1  0/243 (0.00%)  2/109 (1.83%) 
Glossitis  1  0/243 (0.00%)  1/109 (0.92%) 
Intestinal haemorrhage  1  0/243 (0.00%)  1/109 (0.92%) 
Lip ulceration  1  0/243 (0.00%)  1/109 (0.92%) 
Oral pain  1  0/243 (0.00%)  1/109 (0.92%) 
Proctalgia  1  0/243 (0.00%)  1/109 (0.92%) 
Tongue pigmentation  1  0/243 (0.00%)  1/109 (0.92%) 
Toothache  1  0/243 (0.00%)  1/109 (0.92%) 
General disorders     
Fatigue  1  83/243 (34.16%)  38/109 (34.86%) 
Asthenia  1  51/243 (20.99%)  25/109 (22.94%) 
Pyrexia  1  25/243 (10.29%)  7/109 (6.42%) 
Non-cardiac chest pain  1  9/243 (3.70%)  1/109 (0.92%) 
Oedema peripheral  1  8/243 (3.29%)  10/109 (9.17%) 
Chills  1  7/243 (2.88%)  2/109 (1.83%) 
Peripheral swelling  1  6/243 (2.47%)  1/109 (0.92%) 
Influenza like illness  1  4/243 (1.65%)  6/109 (5.50%) 
Malaise  1  4/243 (1.65%)  1/109 (0.92%) 
Pain  1  4/243 (1.65%)  3/109 (2.75%) 
Chest discomfort  1  3/243 (1.23%)  0/109 (0.00%) 
Adverse drug reaction  1  2/243 (0.82%)  0/109 (0.00%) 
Chest pain  1  2/243 (0.82%)  1/109 (0.92%) 
Cyst  1  2/243 (0.82%)  0/109 (0.00%) 
General physical health deterioration  1  2/243 (0.82%)  2/109 (1.83%) 
Injection site bruising  1  2/243 (0.82%)  0/109 (0.00%) 
Mucosal inflammation  1  2/243 (0.82%)  6/109 (5.50%) 
Catheter site erythema  1  1/243 (0.41%)  0/109 (0.00%) 
Catheter site pain  1  1/243 (0.41%)  0/109 (0.00%) 
Early satiety  1  1/243 (0.41%)  0/109 (0.00%) 
Gait disturbance  1  1/243 (0.41%)  0/109 (0.00%) 
Hernia pain  1  1/243 (0.41%)  0/109 (0.00%) 
Hyperpyrexia  1  1/243 (0.41%)  0/109 (0.00%) 
Infusion site reaction  1  1/243 (0.41%)  0/109 (0.00%) 
Injection site swelling  1  1/243 (0.41%)  0/109 (0.00%) 
Catheter site inflammation  1  0/243 (0.00%)  1/109 (0.92%) 
Catheter site rash  1  0/243 (0.00%)  1/109 (0.92%) 
Face oedema  1  0/243 (0.00%)  1/109 (0.92%) 
Injection site reaction  1  0/243 (0.00%)  1/109 (0.92%) 
Localised oedema  1  0/243 (0.00%)  1/109 (0.92%) 
Oedema  1  0/243 (0.00%)  1/109 (0.92%) 
Systemic inflammatory response syndrome  1  0/243 (0.00%)  1/109 (0.92%) 
Hepatobiliary disorders     
Hepatotoxicity  1  2/243 (0.82%)  1/109 (0.92%) 
Hyperbilirubinaemia  1  2/243 (0.82%)  1/109 (0.92%) 
Hepatic function abnormal  1  1/243 (0.41%)  0/109 (0.00%) 
Hepatic pain  1  1/243 (0.41%)  1/109 (0.92%) 
Hypertransaminasaemia  1  1/243 (0.41%)  1/109 (0.92%) 
Immune system disorders     
Drug hypersensitivity  1  1/243 (0.41%)  0/109 (0.00%) 
Hypersensitivity  1  1/243 (0.41%)  1/109 (0.92%) 
Infusion related reaction  1  1/243 (0.41%)  0/109 (0.00%) 
Contrast media allergy  1  0/243 (0.00%)  1/109 (0.92%) 
Food allergy  1  0/243 (0.00%)  1/109 (0.92%) 
Seasonal allergy  1  0/243 (0.00%)  1/109 (0.92%) 
Infections and infestations     
Urinary tract infection  1  28/243 (11.52%)  11/109 (10.09%) 
Nasopharyngitis  1  11/243 (4.53%)  4/109 (3.67%) 
Upper respiratory tract infection  1  9/243 (3.70%)  3/109 (2.75%) 
Cystitis  1  7/243 (2.88%)  3/109 (2.75%) 
Influenza  1  6/243 (2.47%)  3/109 (2.75%) 
Conjunctivitis  1  5/243 (2.06%)  5/109 (4.59%) 
Respiratory tract infection  1  5/243 (2.06%)  3/109 (2.75%) 
Pharyngitis  1  4/243 (1.65%)  0/109 (0.00%) 
Gastroenteritis  1  3/243 (1.23%)  0/109 (0.00%) 
Pneumonia  1  3/243 (1.23%)  1/109 (0.92%) 
Sinusitis  1  3/243 (1.23%)  0/109 (0.00%) 
Cellulitis  1  2/243 (0.82%)  1/109 (0.92%) 
Ear infection  1  2/243 (0.82%)  0/109 (0.00%) 
Gingivitis  1  2/243 (0.82%)  0/109 (0.00%) 
Herpes zoster  1  2/243 (0.82%)  0/109 (0.00%) 
Oral herpes  1  2/243 (0.82%)  2/109 (1.83%) 
Viral upper respiratory tract infection  1  2/243 (0.82%)  0/109 (0.00%) 
Candida infection  1  1/243 (0.41%)  0/109 (0.00%) 
Clostridium difficile infection  1  1/243 (0.41%)  0/109 (0.00%) 
Fungal infection  1  1/243 (0.41%)  0/109 (0.00%) 
Gastrointestinal infection  1  1/243 (0.41%)  0/109 (0.00%) 
Hordeolum  1  1/243 (0.41%)  0/109 (0.00%) 
Keratitis bacterial  1  1/243 (0.41%)  0/109 (0.00%) 
Kidney infection  1  1/243 (0.41%)  0/109 (0.00%) 
Mucosal infection  1  1/243 (0.41%)  0/109 (0.00%) 
Onychomycosis  1  1/243 (0.41%)  1/109 (0.92%) 
Oral fungal infection  1  1/243 (0.41%)  0/109 (0.00%) 
Otitis externa  1  1/243 (0.41%)  0/109 (0.00%) 
Otitis media  1  1/243 (0.41%)  0/109 (0.00%) 
Pyelonephritis  1  1/243 (0.41%)  0/109 (0.00%) 
Pyuria  1  1/243 (0.41%)  0/109 (0.00%) 
Rectal abscess  1  1/243 (0.41%)  0/109 (0.00%) 
Respiratory tract infection viral  1  1/243 (0.41%)  0/109 (0.00%) 
Rhinitis  1  1/243 (0.41%)  1/109 (0.92%) 
Vaginal infection  1  1/243 (0.41%)  0/109 (0.00%) 
Vestibular neuronitis  1  1/243 (0.41%)  0/109 (0.00%) 
Vulvovaginal candidiasis  1  1/243 (0.41%)  0/109 (0.00%) 
Application site folliculitis  1  0/243 (0.00%)  1/109 (0.92%) 
Bacteraemia  1  0/243 (0.00%)  1/109 (0.92%) 
Bacteriuria  1  0/243 (0.00%)  2/109 (1.83%) 
Bronchitis  1  0/243 (0.00%)  2/109 (1.83%) 
Device related infection  1  0/243 (0.00%)  1/109 (0.92%) 
Folliculitis  1  0/243 (0.00%)  1/109 (0.92%) 
Furuncle  1  0/243 (0.00%)  1/109 (0.92%) 
Groin infection  1  0/243 (0.00%)  1/109 (0.92%) 
Herpes simplex  1  0/243 (0.00%)  1/109 (0.92%) 
Klebsiella infection  1  0/243 (0.00%)  1/109 (0.92%) 
Laryngitis  1  0/243 (0.00%)  1/109 (0.92%) 
Localised infection  1  0/243 (0.00%)  1/109 (0.92%) 
Lymphangitis  1  0/243 (0.00%)  1/109 (0.92%) 
Nail infection  1  0/243 (0.00%)  2/109 (1.83%) 
Nasal herpes  1  0/243 (0.00%)  1/109 (0.92%) 
Urethritis  1  0/243 (0.00%)  1/109 (0.92%) 
Urosepsis  1  0/243 (0.00%)  1/109 (0.92%) 
Viral infection  1  0/243 (0.00%)  1/109 (0.92%) 
Injury, poisoning and procedural complications     
Infusion related reaction  1  7/243 (2.88%)  1/109 (0.92%) 
Fall  1  6/243 (2.47%)  4/109 (3.67%) 
Contusion  1  3/243 (1.23%)  1/109 (0.92%) 
Ligament sprain  1  3/243 (1.23%)  0/109 (0.00%) 
Laceration  1  2/243 (0.82%)  1/109 (0.92%) 
Abdominal wall wound  1  1/243 (0.41%)  0/109 (0.00%) 
Acetabulum fracture  1  1/243 (0.41%)  0/109 (0.00%) 
Animal bite  1  1/243 (0.41%)  0/109 (0.00%) 
Ankle fracture  1  1/243 (0.41%)  0/109 (0.00%) 
Corneal abrasion  1  1/243 (0.41%)  0/109 (0.00%) 
Facial bones fracture  1  1/243 (0.41%)  0/109 (0.00%) 
Humerus fracture  1  1/243 (0.41%)  0/109 (0.00%) 
Incision site pain  1  1/243 (0.41%)  0/109 (0.00%) 
Incisional hernia  1  1/243 (0.41%)  0/109 (0.00%) 
Lip injury  1  1/243 (0.41%)  0/109 (0.00%) 
Lumbar vertebral fracture  1  1/243 (0.41%)  0/109 (0.00%) 
Muscle strain  1  1/243 (0.41%)  0/109 (0.00%) 
Overdose  1  1/243 (0.41%)  0/109 (0.00%) 
Post procedural haemorrhage  1  1/243 (0.41%)  0/109 (0.00%) 
Rib fracture  1  1/243 (0.41%)  0/109 (0.00%) 
Scratch  1  1/243 (0.41%)  0/109 (0.00%) 
Superficial injury of eye  1  1/243 (0.41%)  0/109 (0.00%) 
Thermal burn  1  1/243 (0.41%)  0/109 (0.00%) 
Tooth fracture  1  1/243 (0.41%)  0/109 (0.00%) 
Arthropod sting  1  0/243 (0.00%)  1/109 (0.92%) 
Joint dislocation  1  0/243 (0.00%)  1/109 (0.92%) 
Medication error  1  0/243 (0.00%)  1/109 (0.92%) 
Pelvic fracture  1  0/243 (0.00%)  1/109 (0.92%) 
Skin abrasion  1  0/243 (0.00%)  1/109 (0.92%) 
Investigations     
Aspartate aminotransferase increased  1  43/243 (17.70%)  8/109 (7.34%) 
Alanine aminotransferase increased  1  40/243 (16.46%)  6/109 (5.50%) 
Blood alkaline phosphatase increased  1  19/243 (7.82%)  4/109 (3.67%) 
Weight decreased  1  17/243 (7.00%)  4/109 (3.67%) 
Gamma-glutamyltransferase increased  1  7/243 (2.88%)  1/109 (0.92%) 
Blood creatinine increased  1  6/243 (2.47%)  2/109 (1.83%) 
Transaminases increased  1  5/243 (2.06%)  0/109 (0.00%) 
Intraocular pressure increased  1  4/243 (1.65%)  0/109 (0.00%) 
Weight increased  1  4/243 (1.65%)  0/109 (0.00%) 
Activated partial thromboplastin time prolonged  1  3/243 (1.23%)  0/109 (0.00%) 
Blood bilirubin increased  1  2/243 (0.82%)  0/109 (0.00%) 
Hepatic enzyme increased  1  2/243 (0.82%)  0/109 (0.00%) 
Urine leukocyte esterase positive  1  2/243 (0.82%)  0/109 (0.00%) 
Alanine aminotransferase  1  1/243 (0.41%)  0/109 (0.00%) 
Blood alkaline phosphatase  1  1/243 (0.41%)  0/109 (0.00%) 
Blood chloride decreased  1  1/243 (0.41%)  1/109 (0.92%) 
Blood creatine increased  1  1/243 (0.41%)  1/109 (0.92%) 
Blood creatine phosphokinase increased  1  1/243 (0.41%)  0/109 (0.00%) 
Blood creatinine  1  1/243 (0.41%)  0/109 (0.00%) 
Blood fibrinogen increased  1  1/243 (0.41%)  0/109 (0.00%) 
Blood glucose increased  1  1/243 (0.41%)  0/109 (0.00%) 
Blood iron decreased  1  1/243 (0.41%)  0/109 (0.00%) 
Blood pressure increased  1  1/243 (0.41%)  1/109 (0.92%) 
Blood uric acid increased  1  1/243 (0.41%)  0/109 (0.00%) 
Blood urine present  1  1/243 (0.41%)  0/109 (0.00%) 
Cardiac murmur  1  1/243 (0.41%)  0/109 (0.00%) 
Ejection fraction decreased  1  1/243 (0.41%)  0/109 (0.00%) 
Gamma-glutamyltransferase  1  1/243 (0.41%)  0/109 (0.00%) 
Haematocrit decreased  1  1/243 (0.41%)  1/109 (0.92%) 
International normalised ratio increased  1  1/243 (0.41%)  0/109 (0.00%) 
Intestinal transit time decreased  1  1/243 (0.41%)  0/109 (0.00%) 
Lipase increased  1  1/243 (0.41%)  0/109 (0.00%) 
Mean cell haemoglobin decreased  1  1/243 (0.41%)  0/109 (0.00%) 
Protein total decreased  1  1/243 (0.41%)  0/109 (0.00%) 
Protein urine present  1  1/243 (0.41%)  0/109 (0.00%) 
Prothrombin time prolonged  1  1/243 (0.41%)  0/109 (0.00%) 
Urobilinogen urine increased  1  1/243 (0.41%)  0/109 (0.00%) 
Breath sounds abnormal  1  0/243 (0.00%)  1/109 (0.92%) 
Carbohydrate antigen 125 increased  1  0/243 (0.00%)  1/109 (0.92%) 
Eastern Cooperative Oncology Group performance status worsened  1  0/243 (0.00%)  1/109 (0.92%) 
Procalcitonin increased  1  0/243 (0.00%)  1/109 (0.92%) 
Metabolism and nutrition disorders     
Decreased appetite  1  60/243 (24.69%)  16/109 (14.68%) 
Hypomagnesaemia  1  40/243 (16.46%)  10/109 (9.17%) 
Hypokalaemia  1  18/243 (7.41%)  9/109 (8.26%) 
Hypoalbuminaemia  1  14/243 (5.76%)  3/109 (2.75%) 
Hyperglycaemia  1  12/243 (4.94%)  4/109 (3.67%) 
Dehydration  1  9/243 (3.70%)  2/109 (1.83%) 
Hyponatraemia  1  9/243 (3.70%)  6/109 (5.50%) 
Hypophosphataemia  1  6/243 (2.47%)  1/109 (0.92%) 
Hyperuricaemia  1  5/243 (2.06%)  2/109 (1.83%) 
Hypocalcaemia  1  5/243 (2.06%)  2/109 (1.83%) 
Hypercalcaemia  1  3/243 (1.23%)  0/109 (0.00%) 
Failure to thrive  1  1/243 (0.41%)  0/109 (0.00%) 
Hyperkalaemia  1  1/243 (0.41%)  2/109 (1.83%) 
Tumour lysis syndrome  1  1/243 (0.41%)  0/109 (0.00%) 
Type 2 diabetes mellitus  1  1/243 (0.41%)  0/109 (0.00%) 
Vitamin D deficiency  1  1/243 (0.41%)  0/109 (0.00%) 
Hypercreatininaemia  1  0/243 (0.00%)  1/109 (0.92%) 
Iron deficiency  1  0/243 (0.00%)  1/109 (0.92%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  37/243 (15.23%)  7/109 (6.42%) 
Muscle spasms  1  25/243 (10.29%)  4/109 (3.67%) 
Back pain  1  23/243 (9.47%)  9/109 (8.26%) 
Myalgia  1  22/243 (9.05%)  5/109 (4.59%) 
Pain in extremity  1  15/243 (6.17%)  7/109 (6.42%) 
Muscular weakness  1  12/243 (4.94%)  3/109 (2.75%) 
Musculoskeletal pain  1  12/243 (4.94%)  4/109 (3.67%) 
Flank pain  1  4/243 (1.65%)  2/109 (1.83%) 
Bone pain  1  3/243 (1.23%)  3/109 (2.75%) 
Groin pain  1  3/243 (1.23%)  1/109 (0.92%) 
Mobility decreased  1  3/243 (1.23%)  1/109 (0.92%) 
Musculoskeletal chest pain  1  3/243 (1.23%)  2/109 (1.83%) 
Neck pain  1  3/243 (1.23%)  0/109 (0.00%) 
Arthritis  1  2/243 (0.82%)  0/109 (0.00%) 
Musculoskeletal stiffness  1  2/243 (0.82%)  0/109 (0.00%) 
Exostosis  1  1/243 (0.41%)  0/109 (0.00%) 
Joint stiffness  1  1/243 (0.41%)  0/109 (0.00%) 
Joint swelling  1  1/243 (0.41%)  0/109 (0.00%) 
Muscle contracture  1  1/243 (0.41%)  0/109 (0.00%) 
Musculoskeletal discomfort  1  1/243 (0.41%)  0/109 (0.00%) 
Osteitis  1  1/243 (0.41%)  0/109 (0.00%) 
Pain in jaw  1  1/243 (0.41%)  1/109 (0.92%) 
Plantar fasciitis  1  1/243 (0.41%)  0/109 (0.00%) 
Synovial cyst  1  1/243 (0.41%)  0/109 (0.00%) 
Trismus  1  1/243 (0.41%)  0/109 (0.00%) 
Costochondritis  1  0/243 (0.00%)  1/109 (0.92%) 
Joint range of motion decreased  1  0/243 (0.00%)  1/109 (0.92%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acrochordon  1  1/243 (0.41%)  0/109 (0.00%) 
Breast cancer  1  1/243 (0.41%)  0/109 (0.00%) 
Invasive ductal breast carcinoma  1  1/243 (0.41%)  0/109 (0.00%) 
Malignant ascites  1  1/243 (0.41%)  0/109 (0.00%) 
Seborrhoeic keratosis  1  1/243 (0.41%)  0/109 (0.00%) 
Cancer pain  1  0/243 (0.00%)  1/109 (0.92%) 
Lymphangiosis carcinomatosa  1  0/243 (0.00%)  1/109 (0.92%) 
Nervous system disorders     
Headache  1  57/243 (23.46%)  14/109 (12.84%) 
Neuropathy peripheral  1  48/243 (19.75%)  8/109 (7.34%) 
Dysgeusia  1  30/243 (12.35%)  9/109 (8.26%) 
Peripheral sensory neuropathy  1  25/243 (10.29%)  11/109 (10.09%) 
Dizziness  1  16/243 (6.58%)  3/109 (2.75%) 
Paraesthesia  1  15/243 (6.17%)  5/109 (4.59%) 
Neurotoxicity  1  9/243 (3.70%)  6/109 (5.50%) 
Hypoaesthesia  1  5/243 (2.06%)  0/109 (0.00%) 
Sciatica  1  4/243 (1.65%)  0/109 (0.00%) 
Syncope  1  3/243 (1.23%)  0/109 (0.00%) 
Balance disorder  1  2/243 (0.82%)  0/109 (0.00%) 
Disturbance in attention  1  2/243 (0.82%)  0/109 (0.00%) 
Lethargy  1  2/243 (0.82%)  0/109 (0.00%) 
Neuralgia  1  2/243 (0.82%)  1/109 (0.92%) 
Peripheral motor neuropathy  1  2/243 (0.82%)  0/109 (0.00%) 
Presyncope  1  2/243 (0.82%)  0/109 (0.00%) 
Tremor  1  2/243 (0.82%)  1/109 (0.92%) 
Amnesia  1  1/243 (0.41%)  0/109 (0.00%) 
Aphasia  1  1/243 (0.41%)  0/109 (0.00%) 
Aphonia  1  1/243 (0.41%)  0/109 (0.00%) 
Burning sensation  1  1/243 (0.41%)  1/109 (0.92%) 
Dysaesthesia  1  1/243 (0.41%)  0/109 (0.00%) 
Dyskinesia  1  1/243 (0.41%)  0/109 (0.00%) 
Memory impairment  1  1/243 (0.41%)  1/109 (0.92%) 
Migraine  1  1/243 (0.41%)  0/109 (0.00%) 
Sensorimotor disorder  1  1/243 (0.41%)  0/109 (0.00%) 
Somnolence  1  1/243 (0.41%)  0/109 (0.00%) 
Tension headache  1  1/243 (0.41%)  0/109 (0.00%) 
Ageusia  1  0/243 (0.00%)  1/109 (0.92%) 
Drooling  1  0/243 (0.00%)  1/109 (0.92%) 
Mental impairment  1  0/243 (0.00%)  1/109 (0.92%) 
Sensory disturbance  1  0/243 (0.00%)  1/109 (0.92%) 
Product Issues     
Device dislocation  1  1/243 (0.41%)  0/109 (0.00%) 
Psychiatric disorders     
Insomnia  1  23/243 (9.47%)  16/109 (14.68%) 
Anxiety  1  14/243 (5.76%)  8/109 (7.34%) 
Depression  1  6/243 (2.47%)  2/109 (1.83%) 
Agitation  1  2/243 (0.82%)  1/109 (0.92%) 
Depressed mood  1  2/243 (0.82%)  0/109 (0.00%) 
Abnormal dreams  1  1/243 (0.41%)  0/109 (0.00%) 
Confusional state  1  1/243 (0.41%)  0/109 (0.00%) 
Initial insomnia  1  1/243 (0.41%)  0/109 (0.00%) 
Irritability  1  1/243 (0.41%)  0/109 (0.00%) 
Mental disorder  1  1/243 (0.41%)  0/109 (0.00%) 
Nightmare  1  1/243 (0.41%)  0/109 (0.00%) 
Restlessness  1  1/243 (0.41%)  0/109 (0.00%) 
Suicidal ideation  1  1/243 (0.41%)  0/109 (0.00%) 
Tangentiality  1  1/243 (0.41%)  0/109 (0.00%) 
Sleep disorder  1  0/243 (0.00%)  1/109 (0.92%) 
Renal and urinary disorders     
Haematuria  1  7/243 (2.88%)  2/109 (1.83%) 
Pollakiuria  1  6/243 (2.47%)  1/109 (0.92%) 
Dysuria  1  5/243 (2.06%)  4/109 (3.67%) 
Micturition urgency  1  4/243 (1.65%)  0/109 (0.00%) 
Urinary incontinence  1  4/243 (1.65%)  0/109 (0.00%) 
Proteinuria  1  2/243 (0.82%)  1/109 (0.92%) 
Urinary retention  1  2/243 (0.82%)  0/109 (0.00%) 
Urinary tract obstruction  1  2/243 (0.82%)  0/109 (0.00%) 
Acute kidney injury  1  1/243 (0.41%)  0/109 (0.00%) 
Bladder irritation  1  1/243 (0.41%)  0/109 (0.00%) 
Bladder spasm  1  1/243 (0.41%)  0/109 (0.00%) 
Chronic kidney disease  1  1/243 (0.41%)  0/109 (0.00%) 
Hydronephrosis  1  1/243 (0.41%)  1/109 (0.92%) 
Leukocyturia  1  1/243 (0.41%)  0/109 (0.00%) 
Nephrolithiasis  1  1/243 (0.41%)  0/109 (0.00%) 
Nocturia  1  1/243 (0.41%)  0/109 (0.00%) 
Polyuria  1  1/243 (0.41%)  0/109 (0.00%) 
Ureteric dilatation  1  1/243 (0.41%)  0/109 (0.00%) 
Urethral haemorrhage  1  1/243 (0.41%)  0/109 (0.00%) 
Oliguria  1  0/243 (0.00%)  1/109 (0.92%) 
Reproductive system and breast disorders     
Vaginal haemorrhage  1  4/243 (1.65%)  1/109 (0.92%) 
Dyspareunia  1  2/243 (0.82%)  0/109 (0.00%) 
Pelvic pain  1  2/243 (0.82%)  1/109 (0.92%) 
Vulvovaginal pain  1  2/243 (0.82%)  0/109 (0.00%) 
Vulvovaginal pruritus  1  2/243 (0.82%)  1/109 (0.92%) 
Vaginal discharge  1  1/243 (0.41%)  0/109 (0.00%) 
Vaginal fistula  1  1/243 (0.41%)  0/109 (0.00%) 
Vulvovaginal dryness  1  1/243 (0.41%)  1/109 (0.92%) 
Rectocele  1  0/243 (0.00%)  1/109 (0.92%) 
Vulva cyst  1  0/243 (0.00%)  1/109 (0.92%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  39/243 (16.05%)  15/109 (13.76%) 
Dyspnoea  1  36/243 (14.81%)  16/109 (14.68%) 
Pneumonitis  1  13/243 (5.35%)  1/109 (0.92%) 
Nasal congestion  1  9/243 (3.70%)  1/109 (0.92%) 
Epistaxis  1  8/243 (3.29%)  5/109 (4.59%) 
Oropharyngeal pain  1  6/243 (2.47%)  4/109 (3.67%) 
Pleural effusion  1  5/243 (2.06%)  3/109 (2.75%) 
Dysphonia  1  4/243 (1.65%)  2/109 (1.83%) 
Productive cough  1  4/243 (1.65%)  2/109 (1.83%) 
Dyspnoea exertional  1  3/243 (1.23%)  0/109 (0.00%) 
Lung disorder  1  3/243 (1.23%)  0/109 (0.00%) 
Pulmonary embolism  1  3/243 (1.23%)  1/109 (0.92%) 
Pleuritic pain  1  2/243 (0.82%)  0/109 (0.00%) 
Rhinorrhoea  1  2/243 (0.82%)  0/109 (0.00%) 
Sinus congestion  1  2/243 (0.82%)  0/109 (0.00%) 
Bronchospasm  1  1/243 (0.41%)  0/109 (0.00%) 
Haemothorax  1  1/243 (0.41%)  0/109 (0.00%) 
Hypoxia  1  1/243 (0.41%)  0/109 (0.00%) 
Interstitial lung disease  1  1/243 (0.41%)  0/109 (0.00%) 
Organising pneumonia  1  1/243 (0.41%)  0/109 (0.00%) 
Pneumothorax  1  1/243 (0.41%)  0/109 (0.00%) 
Pulmonary fibrosis  1  1/243 (0.41%)  0/109 (0.00%) 
Pulmonary pain  1  1/243 (0.41%)  0/109 (0.00%) 
Pulmonary toxicity  1  1/243 (0.41%)  0/109 (0.00%) 
Rales  1  1/243 (0.41%)  0/109 (0.00%) 
Sinus pain  1  1/243 (0.41%)  0/109 (0.00%) 
Sputum retention  1  1/243 (0.41%)  0/109 (0.00%) 
Allergic sinusitis  1  0/243 (0.00%)  1/109 (0.92%) 
Nasal dryness  1  0/243 (0.00%)  1/109 (0.92%) 
Nasal inflammation  1  0/243 (0.00%)  1/109 (0.92%) 
Orthopnoea  1  0/243 (0.00%)  1/109 (0.92%) 
Rhinitis allergic  1  0/243 (0.00%)  1/109 (0.92%) 
Stridor  1  0/243 (0.00%)  1/109 (0.92%) 
Upper respiratory tract congestion  1  0/243 (0.00%)  1/109 (0.92%) 
Upper-airway cough syndrome  1  0/243 (0.00%)  1/109 (0.92%) 
Wheezing  1  0/243 (0.00%)  2/109 (1.83%) 
Skin and subcutaneous tissue disorders     
Pruritus  1  12/243 (4.94%)  7/109 (6.42%) 
Rash  1  10/243 (4.12%)  12/109 (11.01%) 
Alopecia  1  7/243 (2.88%)  14/109 (12.84%) 
Erythema  1  7/243 (2.88%)  6/109 (5.50%) 
Dry skin  1  4/243 (1.65%)  8/109 (7.34%) 
Hyperhidrosis  1  3/243 (1.23%)  1/109 (0.92%) 
Photosensitivity reaction  1  3/243 (1.23%)  1/109 (0.92%) 
Night sweats  1  2/243 (0.82%)  1/109 (0.92%) 
Petechiae  1  2/243 (0.82%)  0/109 (0.00%) 
Rash maculo-papular  1  2/243 (0.82%)  4/109 (3.67%) 
Blood blister  1  1/243 (0.41%)  0/109 (0.00%) 
Dermal cyst  1  1/243 (0.41%)  0/109 (0.00%) 
Lentigo  1  1/243 (0.41%)  0/109 (0.00%) 
Madarosis  1  1/243 (0.41%)  0/109 (0.00%) 
Nail discolouration  1  1/243 (0.41%)  1/109 (0.92%) 
Onychoclasis  1  1/243 (0.41%)  0/109 (0.00%) 
Palmar-plantar erythrodysaesthesia syndrome  1  1/243 (0.41%)  16/109 (14.68%) 
Papule  1  1/243 (0.41%)  0/109 (0.00%) 
Rash generalised  1  1/243 (0.41%)  1/109 (0.92%) 
Rash papular  1  1/243 (0.41%)  0/109 (0.00%) 
Skin lesion  1  1/243 (0.41%)  0/109 (0.00%) 
Urticaria  1  1/243 (0.41%)  0/109 (0.00%) 
Blister  1  0/243 (0.00%)  1/109 (0.92%) 
Dermatitis  1  0/243 (0.00%)  1/109 (0.92%) 
Dermatitis acneiform  1  0/243 (0.00%)  2/109 (1.83%) 
Erythema multiforme  1  0/243 (0.00%)  1/109 (0.92%) 
Hyperkeratosis  1  0/243 (0.00%)  1/109 (0.92%) 
Nail disorder  1  0/243 (0.00%)  5/109 (4.59%) 
Nail dystrophy  1  0/243 (0.00%)  1/109 (0.92%) 
Nail toxicity  1  0/243 (0.00%)  2/109 (1.83%) 
Onychalgia  1  0/243 (0.00%)  1/109 (0.92%) 
Onycholysis  1  0/243 (0.00%)  4/109 (3.67%) 
Onychomadesis  1  0/243 (0.00%)  1/109 (0.92%) 
Pain of skin  1  0/243 (0.00%)  1/109 (0.92%) 
Pigmentation disorder  1  0/243 (0.00%)  1/109 (0.92%) 
Skin exfoliation  1  0/243 (0.00%)  1/109 (0.92%) 
Skin fissures  1  0/243 (0.00%)  1/109 (0.92%) 
Skin hyperpigmentation  1  0/243 (0.00%)  4/109 (3.67%) 
Skin irritation  1  0/243 (0.00%)  1/109 (0.92%) 
Skin toxicity  1  0/243 (0.00%)  1/109 (0.92%) 
Umbilical haemorrhage  1  0/243 (0.00%)  1/109 (0.92%) 
Surgical and medical procedures     
Wound drainage  1  0/243 (0.00%)  1/109 (0.92%) 
Vascular disorders     
Hypertension  1  16/243 (6.58%)  4/109 (3.67%) 
Flushing  1  8/243 (3.29%)  1/109 (0.92%) 
Hot flush  1  6/243 (2.47%)  3/109 (2.75%) 
Haematoma  1  3/243 (1.23%)  0/109 (0.00%) 
Deep vein thrombosis  1  2/243 (0.82%)  0/109 (0.00%) 
Embolism  1  2/243 (0.82%)  0/109 (0.00%) 
Hypotension  1  1/243 (0.41%)  2/109 (1.83%) 
Pelvic venous thrombosis  1  1/243 (0.41%)  0/109 (0.00%) 
Phlebitis  1  1/243 (0.41%)  0/109 (0.00%) 
Subclavian vein thrombosis  1  1/243 (0.41%)  0/109 (0.00%) 
Thrombophlebitis  1  1/243 (0.41%)  0/109 (0.00%) 
Lymphoedema  1  0/243 (0.00%)  2/109 (1.83%) 
Varicose vein  1  0/243 (0.00%)  1/109 (0.92%) 
Vasculitis  1  0/243 (0.00%)  1/109 (0.92%) 
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: CMO, ImmunoGen
Organization: ImmunoGen, Inc
Phone: 781-895-0600
EMail: clinicaltrials@immunogen.com
Layout table for additonal information
Responsible Party: ImmunoGen, Inc.
ClinicalTrials.gov Identifier: NCT02631876    
Other Study ID Numbers: IMGN853-0403
First Submitted: December 10, 2015
First Posted: December 16, 2015
Results First Submitted: May 6, 2020
Results First Posted: June 9, 2020
Last Update Posted: October 14, 2020