A Study of Mirvetuximab Soravtansine vs. Investigator's C... | NCT02631876

NCT02631876

Status Module

Name	Class
Gynecologic Oncology Group	NETWORK

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mirvetuximab Soravtansine	Experimental	Participants will receive 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 will continue to receive study drug until they experience progressive disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (as assessed by the blinded independent review committee [BIRC]), experience unacceptable toxicity, or withdraw consent, whichever comes first, or until the sponsor terminate the study. (Maximum exposure: 86.9 weeks)	Drug: Mirvetuximab soravtansine
Investigator's Choice (IC) Chemotherapy	Experimental	Participants will receive a dose of IC chemotherapeutic agent calculated using body surface area (BSA). Paclitaxel will be 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 will be administered at 4 mg/m^2 over 30 minutes on Days 1, 8, and 15 of a 4-week cycle. Alternatively, topotecan could be administered at 1.25 mg/m^2 over 30 minutes on Days 1 to 5 of a 3-week cycle; or pegylated liposomal doxorubicin will be 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 be administered as a 1-hour infusion. Participants will continue to receive study drug until they experience PD per RECIST version 1.1 (as assessed by BIRC), experience unacceptable toxicity, or withdraw consent, whichever comes first, or until the sponsor terminate the study. (Maximum exposure: 62.9 weeks)	Drug: Paclitaxel Drug: Pegylated liposomal doxorubicin Drug: Topotecan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mirvetuximab soravtansine	Drug	Mirvetuximab Soravtansine will be administered per dose and schedule specified in the arm.	Mirvetuximab Soravtansine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-Free Survival (PFS), as Assessed by BIRC Per RECIST Version 1.1 in All Participants Randomized to the Study	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.	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)
PFS, as Assessed by BIRC Per RECIST Version 1.1 in Participants With High Folate Receptor Alpha Level (≥ 75% of Tumor Staining)	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.	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)

Secondary Outcomes

Measure	Description	Time Frame
Objective Response Rate (ORR): Percentage of Participants With Objective Response, as Assessed by BIRC Per RECIST1.1	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 SoD of target lesions, taking as reference the baseline SoD.

Eligibility Module

Name	Affiliation	Role
CMO ImmunoGen	ImmunoGen, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35294	United States
Arizona Oncology Associates, PC - HAL

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33667670	Derived	Moore KN, Oza AM, Colombo N, Oaknin A, Scambia G, Lorusso D, Konecny GE, Banerjee S, Murphy CG, Tanyi JL, Hirte H, Konner JA, Lim PC, Prasad-Hayes M, Monk BJ, Pautier P, Wang J, Berkenblit A, Vergote I, Birrer MJ. Phase III, randomized trial of mirvetuximab soravtansine versus chemotherapy in patients with platinum-resistant ovarian cancer: primary analysis of FORWARD I. Ann Oncol. 2021 Jun;32(6):757-765. doi: 10.1016/j.annonc.2021.02.017. Epub 2021 Mar 2.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Mirvetuximab Soravtansine	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)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
SAP	No	Yes	No	Statistical Analysis Plan	Mar 3, 2020	May 20, 2020

Arm/Group Information

ID	Title	Description
BG000	Mirvetuximab Soravtansine	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)
BG001	Investigator's Choice (IC) Chemotherapy	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)
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00062.7± 10.29 BG00162.9± 10.51 BG00262.8± 10.35

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000248 BG001118 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00012 BG0019 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0011 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

Progression-Free Survival (PFS), as Assessed by BIRC Per RECIST Version 1.1 in All Participants Randomized to the Study

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.

ITT population included all participants randomized in the study.

Posted

Median

95% Confidence Interval

months

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)

ID	Title	Description
OG000	Mirvetuximab Soravtansine	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)
OG001	Investigator's Choice (IC) Chemotherapy	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)

Units	Counts
Participants	OG000248 OG001118

Title

Denominators

Categories

Title	Measurements
	OG0004.14(3.75 to 4.53) OG0014.44(2.83 to 5.59)

Primary

PFS, as Assessed by BIRC Per RECIST Version 1.1 in Participants With High Folate Receptor Alpha Level (≥ 75% of Tumor Staining)

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.

ITT population included all participants randomized in the study. Here, overall number of participants analyzed signifies participants with high folate receptor alpha level.

Posted

Median

95% Confidence Interval

months

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)

ID	Title	Description
OG000	Mirvetuximab Soravtansine	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)
OG001

Secondary

Objective Response Rate (ORR): Percentage of Participants With Objective Response, as Assessed by BIRC Per RECIST1.1

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 SoD of target lesions, taking as reference the baseline SoD.

ITT population included all participants randomized in the study.

Posted

Number

95% Confidence Interval

percentage of participants

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)

ID	Title	Description
OG000	Mirvetuximab Soravtansine	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)
OG001	Investigator's Choice (IC) Chemotherapy	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)

Secondary

Overall Survival (OS)

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.

ITT population included all participants randomized in the study.

Posted

Median

95% Confidence Interval

months

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)

ID	Title	Description
OG000	Mirvetuximab Soravtansine	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)
OG001	Investigator's Choice (IC) Chemotherapy	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)

Secondary

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

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.

ITT population included all participants randomized in the study. Here, 'overall number of participants analyzed' signifies participants evaluable for this outcome measure.

Posted

Count of Participants

Participants

Baseline, Week 8/9

ID	Title	Description
OG000	Mirvetuximab Soravtansine	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)

Secondary

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

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.

Safety population included all enrolled participants who received at least 1 dose of mirvetuximab soravtansine or IC chemotherapy.

Posted

Count of Participants

Participants

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)

ID	Title	Description
OG000	Mirvetuximab Soravtansine	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)

Secondary

Gynecologic Cancer Intergroup (GCIG) CA-125 Response Rate: Percentage of Participants With GCIG CA-125 Confirmed Clinical Responses

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.

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.

Posted

Number

95% Confidence Interval

percentage of participants

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)

ID	Title	Description
OG000	Mirvetuximab Soravtansine	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)
OG001	Investigator's Choice (IC) Chemotherapy	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)

Secondary

PFS, as Assessed by Investigator Per RECIST Version 1.1

ITT population included all participants randomized in the study.

Posted

Median

95% Confidence Interval

months

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)

ID	Title	Description
OG000	Mirvetuximab Soravtansine	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)
OG001	Investigator's Choice (IC) Chemotherapy	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)

Secondary

Duration of Response (DOR), as Assessed by BIRC Per 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 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.

ITT population included all participants randomized in the study. Here, 'overall number of participants analyzed' signifies participants evaluable for this outcome measure.

Posted

Median

95% Confidence Interval

months

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)

ID	Title	Description
OG000	Mirvetuximab Soravtansine	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)
OG001

Secondary

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

PK parameters were calculated using standard non-compartmental methods.

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.

Posted

Mean

Standard Deviation

hours*milligrams/milliliter (hr*mg/mL)

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

ID	Title	Description
OG000	Mirvetuximab Soravtansine	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)

Units	Counts
Participants

Secondary

Number of Participants With Anti-Drug Antibodies (ADA)

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.

Immunogenicity population included all participants who received at least 1 infusion of mirvetuximab soravtansine and had evaluable immunogenicity data.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Mirvetuximab Soravtansine	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)

Units	Counts
Participants	OG000

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	Mirvetuximab Soravtansine	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)	96	243	67	243	242	243
EG001	Investigator's Choice (IC) Chemotherapy	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)	50	109	31	109	106	109

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Intestinal obstruction	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00010 affected243 at risk EG0013 affected109 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0005 affected243 at risk EG0014 affected109 at risk
Constipation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0004 affected243 at risk EG0011 affected109 at risk
Large intestinal obstruction	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0004 affected243 at risk EG0012 affected109 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0012 affected109 at risk
Nausea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0011 affected109 at risk
Vomiting	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0012 affected109 at risk
Abdominal incarcerated hernia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Ascites	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0012 affected109 at risk
Gastritis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0007 affected243 at risk EG0012 affected109 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0005 affected243 at risk EG0013 affected109 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 affected243 at risk EG0010 affected109 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0012 affected109 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 affected243 at risk EG0013 affected109 at risk
Urinary tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0011 affected109 at risk
Campylobacter gastroenteritis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Influenza	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Oesophageal infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Pyelonephritis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Systemic infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Urosepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0011 affected109 at risk
Vestibular neuronitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Salmonellosis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0004 affected243 at risk EG0010 affected109 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Syncope	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0010 affected109 at risk
Headache	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Presyncope	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Asthenia	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Complication associated with device	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0011 affected109 at risk
Fatigue	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
General physical health deterioration	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Pyrexia	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0013 affected109 at risk
Acetabulum fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Cardiac arrest	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0010 affected109 at risk
Eye pain	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Punctate keratitis	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Malignant pleural effusion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Tumour obstruction	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Embolism	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Mania	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG000131 affected243 at risk EG00146 affected109 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG000107 affected243 at risk EG00118 affected109 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00080 affected243 at risk EG00123 affected109 at risk
Constipation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00064 affected243 at risk EG00131 affected109 at risk
Vomiting	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00064 affected243 at risk EG00122 affected109 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00026 affected243 at risk EG00111 affected109 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00018 affected243 at risk EG0015 affected109 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00015 affected243 at risk EG00110 affected109 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00014 affected243 at risk EG0015 affected109 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00011 affected243 at risk EG0012 affected109 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00010 affected243 at risk EG0013 affected109 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00010 affected243 at risk EG00123 affected109 at risk
Ascites	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0009 affected243 at risk EG0016 affected109 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0008 affected243 at risk EG0010 affected109 at risk
Flatulence	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0007 affected243 at risk EG0011 affected109 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0004 affected243 at risk EG0012 affected109 at risk
Aphthous ulcer	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 affected243 at risk EG0011 affected109 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 affected243 at risk EG0011 affected109 at risk
Retching	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 affected243 at risk EG0010 affected109 at risk
Gingival bleeding	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0010 affected109 at risk
Odynophagia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0011 affected109 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0011 affected109 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Abdominal tenderness	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0011 affected109 at risk
Abnormal faeces	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Anal incontinence	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Breath odour	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Coating in mouth	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Colitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Dental caries	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0012 affected109 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0012 affected109 at risk
Enterocolitis haemorrhagic	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Eructation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Faecal vomiting	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Faeces discoloured	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Faeces soft	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Gastrointestinal motility disorder	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0011 affected109 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0011 affected109 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Large intestinal obstruction	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Mouth cyst	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0011 affected109 at risk
Oesophageal pain	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Rectal discharge	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Rectal tenesmus	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Vomiting projectile	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Abdominal mass	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Gastric disorder	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Gastrointestinal obstruction	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Gastrointestinal pain	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0012 affected109 at risk
Glossitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Intestinal haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Lip ulceration	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Oral pain	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Proctalgia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Tongue pigmentation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Toothache	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Fatigue	General disorders	MedDRA 21.0	Systematic Assessment	EG00083 affected243 at risk EG00138 affected109 at risk
Asthenia	General disorders	MedDRA 21.0	Systematic Assessment	EG00051 affected243 at risk EG00125 affected109 at risk
Pyrexia	General disorders	MedDRA 21.0	Systematic Assessment	EG00025 affected243 at risk EG0017 affected109 at risk
Non-cardiac chest pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0009 affected243 at risk EG0011 affected109 at risk
Oedema peripheral	General disorders	MedDRA 21.0	Systematic Assessment	EG0008 affected243 at risk EG00110 affected109 at risk
Chills	General disorders	MedDRA 21.0	Systematic Assessment	EG0007 affected243 at risk EG0012 affected109 at risk
Peripheral swelling	General disorders	MedDRA 21.0	Systematic Assessment	EG0006 affected243 at risk EG0011 affected109 at risk
Influenza like illness	General disorders	MedDRA 21.0	Systematic Assessment	EG0004 affected243 at risk EG0016 affected109 at risk
Malaise	General disorders	MedDRA 21.0	Systematic Assessment	EG0004 affected243 at risk EG0011 affected109 at risk
Pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0004 affected243 at risk EG0013 affected109 at risk
Chest discomfort	General disorders	MedDRA 21.0	Systematic Assessment	EG0003 affected243 at risk EG0010 affected109 at risk
Adverse drug reaction	General disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0010 affected109 at risk
Chest pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0011 affected109 at risk
Cyst	General disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0010 affected109 at risk
General physical health deterioration	General disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0012 affected109 at risk
Injection site bruising	General disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0010 affected109 at risk
Mucosal inflammation	General disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0016 affected109 at risk
Catheter site erythema	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Catheter site pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Early satiety	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Gait disturbance	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Hernia pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Hyperpyrexia	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Infusion site reaction	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Injection site swelling	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Catheter site inflammation	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Catheter site rash	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Face oedema	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Injection site reaction	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Localised oedema	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Oedema	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Vision blurred	Eye disorders	MedDRA 21.0	Systematic Assessment	EG000104 affected243 at risk EG0016 affected109 at risk
Keratopathy	Eye disorders	MedDRA 21.0	Systematic Assessment	EG00077 affected243 at risk EG0011 affected109 at risk
Dry eye	Eye disorders	MedDRA 21.0	Systematic Assessment	EG00068 affected243 at risk EG0012 affected109 at risk
Visual acuity reduced	Eye disorders	MedDRA 21.0	Systematic Assessment	EG00052 affected243 at risk EG0012 affected109 at risk
Cataract	Eye disorders	MedDRA 21.0	Systematic Assessment	EG00036 affected243 at risk EG0012 affected109 at risk
Photophobia	Eye disorders	MedDRA 21.0	Systematic Assessment	EG00034 affected243 at risk EG0012 affected109 at risk
Eye pain	Eye disorders	MedDRA 21.0	Systematic Assessment	EG00031 affected243 at risk EG0011 affected109 at risk
Vitreous floaters	Eye disorders	MedDRA 21.0	Systematic Assessment	EG00013 affected243 at risk EG0010 affected109 at risk
Foreign body sensation in eyes	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0009 affected243 at risk EG0010 affected109 at risk
Visual impairment	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0009 affected243 at risk EG0011 affected109 at risk
Keratitis	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0008 affected243 at risk EG0010 affected109 at risk
Eye irritation	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0007 affected243 at risk EG0010 affected109 at risk
Lacrimation increased	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0006 affected243 at risk EG0011 affected109 at risk
Corneal deposits	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0005 affected243 at risk EG0010 affected109 at risk
Eye pruritus	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0005 affected243 at risk EG0010 affected109 at risk
Ocular discomfort	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0005 affected243 at risk EG0011 affected109 at risk
Punctate keratitis	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0004 affected243 at risk EG0010 affected109 at risk
Blepharitis	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0003 affected243 at risk EG0010 affected109 at risk
Diplopia	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0003 affected243 at risk EG0010 affected109 at risk
Glaucoma	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0003 affected243 at risk EG0010 affected109 at risk
Photopsia	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0003 affected243 at risk EG0010 affected109 at risk
Uveitis	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0003 affected243 at risk EG0010 affected109 at risk
Asthenopia	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0010 affected109 at risk
Chalazion	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0010 affected109 at risk
Conjunctival haemorrhage	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0010 affected109 at risk
Conjunctival hyperaemia	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0010 affected109 at risk
Lacrimation decreased	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0010 affected109 at risk
Metamorphopsia	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0010 affected109 at risk
Ocular hyperaemia	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0010 affected109 at risk
Xerophthalmia	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0010 affected109 at risk
Abnormal sensation in eye	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Acquired corneal dystrophy	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Age-related macular degeneration	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Blepharochalasis	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Cataract nuclear	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Conjunctival irritation	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Corneal cyst	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Corneal oedema	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Dyschromatopsia	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Eye disorder	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Eye inflammation	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Eye swelling	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Eyelid oedema	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Eyelid pain	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Eyelid skin dryness	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Halo vision	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Hypermetropia	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Meibomianitis	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Myopia	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Night blindness	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Ocular hypertension	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Ocular toxicity	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Optic nerve disorder	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Papilloedema	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Periorbital oedema	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Pterygium	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Pupils unequal	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Retinal detachment	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Retinal drusen	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Retinopathy	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Sympathetic ophthalmia	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Trichiasis	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Vitreous detachment	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Headache	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG00057 affected243 at risk EG00114 affected109 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG00048 affected243 at risk EG0018 affected109 at risk
Dysgeusia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG00030 affected243 at risk EG0019 affected109 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG00025 affected243 at risk EG00111 affected109 at risk
Dizziness	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG00016 affected243 at risk EG0013 affected109 at risk
Paraesthesia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG00015 affected243 at risk EG0015 affected109 at risk
Neurotoxicity	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0009 affected243 at risk EG0016 affected109 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0005 affected243 at risk EG0010 affected109 at risk
Sciatica	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0004 affected243 at risk EG0010 affected109 at risk
Syncope	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0003 affected243 at risk EG0010 affected109 at risk
Balance disorder	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0010 affected109 at risk
Disturbance in attention	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0010 affected109 at risk
Lethargy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0010 affected109 at risk
Neuralgia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0011 affected109 at risk
Peripheral motor neuropathy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0010 affected109 at risk
Presyncope	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0010 affected109 at risk
Tremor	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0011 affected109 at risk
Amnesia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Aphasia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Aphonia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Burning sensation	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0011 affected109 at risk
Dysaesthesia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Dyskinesia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Memory impairment	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0011 affected109 at risk
Migraine	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Sensorimotor disorder	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Somnolence	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Tension headache	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Ageusia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Drooling	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Mental impairment	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Sensory disturbance	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG00037 affected243 at risk EG0017 affected109 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG00025 affected243 at risk EG0014 affected109 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG00023 affected243 at risk EG0019 affected109 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG00022 affected243 at risk EG0015 affected109 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG00015 affected243 at risk EG0017 affected109 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG00012 affected243 at risk EG0013 affected109 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG00012 affected243 at risk EG0014 affected109 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0004 affected243 at risk EG0012 affected109 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0003 affected243 at risk EG0013 affected109 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0003 affected243 at risk EG0011 affected109 at risk
Mobility decreased	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0003 affected243 at risk EG0011 affected109 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0003 affected243 at risk EG0012 affected109 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0003 affected243 at risk EG0010 affected109 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0010 affected109 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0010 affected109 at risk
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Joint stiffness	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Muscle contracture	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Osteitis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0011 affected109 at risk
Plantar fasciitis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Trismus	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Joint range of motion decreased	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG00060 affected243 at risk EG00116 affected109 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG00040 affected243 at risk EG00110 affected109 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG00018 affected243 at risk EG0019 affected109 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG00014 affected243 at risk EG0013 affected109 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG00012 affected243 at risk EG0014 affected109 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0009 affected243 at risk EG0012 affected109 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0009 affected243 at risk EG0016 affected109 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0006 affected243 at risk EG0011 affected109 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0005 affected243 at risk EG0012 affected109 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0005 affected243 at risk EG0012 affected109 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0003 affected243 at risk EG0010 affected109 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0012 affected109 at risk
Tumour lysis syndrome	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Hypercreatininaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Iron deficiency	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00039 affected243 at risk EG00115 affected109 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00036 affected243 at risk EG00116 affected109 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00013 affected243 at risk EG0011 affected109 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0009 affected243 at risk EG0011 affected109 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0008 affected243 at risk EG0015 affected109 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0006 affected243 at risk EG0014 affected109 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0005 affected243 at risk EG0013 affected109 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0004 affected243 at risk EG0012 affected109 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0004 affected243 at risk EG0012 affected109 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 affected243 at risk EG0010 affected109 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 affected243 at risk EG0010 affected109 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 affected243 at risk EG0011 affected109 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0010 affected109 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0010 affected109 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0010 affected109 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Organising pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Pulmonary pain	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Pulmonary toxicity	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Rales	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Sinus pain	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Sputum retention	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Allergic sinusitis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Nasal dryness	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Nasal inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Orthopnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Stridor	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Upper respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0012 affected109 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG00043 affected243 at risk EG0018 affected109 at risk
Alanine aminotransferase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG00040 affected243 at risk EG0016 affected109 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG00019 affected243 at risk EG0014 affected109 at risk
Weight decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG00017 affected243 at risk EG0014 affected109 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0007 affected243 at risk EG0011 affected109 at risk
Blood creatinine increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0006 affected243 at risk EG0012 affected109 at risk
Transaminases increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0005 affected243 at risk EG0010 affected109 at risk
Intraocular pressure increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0004 affected243 at risk EG0010 affected109 at risk
Weight increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0004 affected243 at risk EG0010 affected109 at risk
Activated partial thromboplastin time prolonged	Investigations	MedDRA 21.0	Systematic Assessment	EG0003 affected243 at risk EG0010 affected109 at risk
Blood bilirubin increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0010 affected109 at risk
Hepatic enzyme increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0010 affected109 at risk
Urine leukocyte esterase positive	Investigations	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0010 affected109 at risk
Alanine aminotransferase	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Blood alkaline phosphatase	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Blood chloride decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0011 affected109 at risk
Blood creatine increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0011 affected109 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Blood creatinine	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Blood fibrinogen increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Blood glucose increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Blood iron decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Blood pressure increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0011 affected109 at risk
Blood uric acid increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Blood urine present	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Cardiac murmur	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Ejection fraction decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Gamma-glutamyltransferase	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Haematocrit decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0011 affected109 at risk
International normalised ratio increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Intestinal transit time decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Lipase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Mean cell haemoglobin decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Protein total decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Protein urine present	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Prothrombin time prolonged	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Urobilinogen urine increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Breath sounds abnormal	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Carbohydrate antigen 125 increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Eastern Cooperative Oncology Group performance status worsened	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Procalcitonin increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Urinary tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00028 affected243 at risk EG00111 affected109 at risk
Nasopharyngitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00011 affected243 at risk EG0014 affected109 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0009 affected243 at risk EG0013 affected109 at risk
Cystitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0007 affected243 at risk EG0013 affected109 at risk
Influenza	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0006 affected243 at risk EG0013 affected109 at risk
Conjunctivitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0005 affected243 at risk EG0015 affected109 at risk
Respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0005 affected243 at risk EG0013 affected109 at risk
Pharyngitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0004 affected243 at risk EG0010 affected109 at risk
Gastroenteritis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 affected243 at risk EG0010 affected109 at risk
Pneumonia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 affected243 at risk EG0011 affected109 at risk
Sinusitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 affected243 at risk EG0010 affected109 at risk
Cellulitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0011 affected109 at risk
Ear infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0010 affected109 at risk
Gingivitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0010 affected109 at risk
Herpes zoster	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0010 affected109 at risk
Oral herpes	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0012 affected109 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0010 affected109 at risk
Candida infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Clostridium difficile infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Fungal infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Gastrointestinal infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Hordeolum	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Keratitis bacterial	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Kidney infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Mucosal infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Onychomycosis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0011 affected109 at risk
Oral fungal infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Otitis externa	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Otitis media	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Pyelonephritis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Pyuria	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Rectal abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Rhinitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0011 affected109 at risk
Vaginal infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Vestibular neuronitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Vulvovaginal candidiasis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Application site folliculitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Bacteraemia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Bacteriuria	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0012 affected109 at risk
Bronchitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0012 affected109 at risk
Device related infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Folliculitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Furuncle	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Groin infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Herpes simplex	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Klebsiella infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Laryngitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Localised infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Lymphangitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Nail infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0012 affected109 at risk
Nasal herpes	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Urethritis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Urosepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Viral infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG00034 affected243 at risk EG00132 affected109 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG00027 affected243 at risk EG00117 affected109 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG00016 affected243 at risk EG00143 affected109 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0009 affected243 at risk EG00116 affected109 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0008 affected243 at risk EG0013 affected109 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0010 affected109 at risk
Granulomatous lymphadenitis	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Neutrophilia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Thrombocytosis	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG00012 affected243 at risk EG0017 affected109 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG00010 affected243 at risk EG00112 affected109 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0007 affected243 at risk EG00114 affected109 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0007 affected243 at risk EG0016 affected109 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0004 affected243 at risk EG0018 affected109 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0003 affected243 at risk EG0011 affected109 at risk
Photosensitivity reaction	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0003 affected243 at risk EG0011 affected109 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0011 affected109 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0010 affected109 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0014 affected109 at risk
Blood blister	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Lentigo	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Madarosis	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Nail discolouration	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0011 affected109 at risk
Onychoclasis	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG00116 affected109 at risk
Papule	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Rash generalised	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0011 affected109 at risk
Rash papular	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0012 affected109 at risk
Erythema multiforme	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Hyperkeratosis	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Nail disorder	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0015 affected109 at risk
Nail dystrophy	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Nail toxicity	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0012 affected109 at risk
Onychalgia	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Onycholysis	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0014 affected109 at risk
Onychomadesis	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Pain of skin	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Pigmentation disorder	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Skin fissures	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0014 affected109 at risk
Skin irritation	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Skin toxicity	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Umbilical haemorrhage	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Insomnia	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG00023 affected243 at risk EG00116 affected109 at risk
Anxiety	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG00014 affected243 at risk EG0018 affected109 at risk
Depression	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0006 affected243 at risk EG0012 affected109 at risk
Agitation	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0011 affected109 at risk
Depressed mood	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0010 affected109 at risk
Abnormal dreams	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Confusional state	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Initial insomnia	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Irritability	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Mental disorder	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Nightmare	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Restlessness	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Suicidal ideation	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Tangentiality	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Sleep disorder	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Hypertension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG00016 affected243 at risk EG0014 affected109 at risk
Flushing	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0008 affected243 at risk EG0011 affected109 at risk
Hot flush	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0006 affected243 at risk EG0013 affected109 at risk
Haematoma	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0003 affected243 at risk EG0010 affected109 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0010 affected109 at risk
Embolism	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0010 affected109 at risk
Hypotension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0012 affected109 at risk
Pelvic venous thrombosis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Phlebitis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Subclavian vein thrombosis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Thrombophlebitis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Lymphoedema	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0012 affected109 at risk
Varicose vein	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Vasculitis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0007 affected243 at risk EG0011 affected109 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0006 affected243 at risk EG0014 affected109 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0003 affected243 at risk EG0011 affected109 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0003 affected243 at risk EG0010 affected109 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0011 affected109 at risk
Abdominal wall wound	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Acetabulum fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Animal bite	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Corneal abrasion	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Incision site pain	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Lip injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Scratch	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Superficial injury of eye	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Tooth fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Arthropod sting	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Medication error	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Haematuria	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0007 affected243 at risk EG0012 affected109 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0006 affected243 at risk EG0011 affected109 at risk
Dysuria	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0005 affected243 at risk EG0014 affected109 at risk
Micturition urgency	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0004 affected243 at risk EG0010 affected109 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0004 affected243 at risk EG0010 affected109 at risk
Proteinuria	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0011 affected109 at risk
Urinary retention	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0010 affected109 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0010 affected109 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Bladder irritation	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Bladder spasm	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0011 affected109 at risk
Leukocyturia	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Nocturia	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Polyuria	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Ureteric dilatation	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Urethral haemorrhage	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Oliguria	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0004 affected243 at risk EG0011 affected109 at risk
Dyspareunia	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0010 affected109 at risk
Pelvic pain	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0011 affected109 at risk
Vulvovaginal pain	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0010 affected109 at risk
Vulvovaginal pruritus	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0011 affected109 at risk
Vaginal discharge	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Vaginal fistula	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Vulvovaginal dryness	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0011 affected109 at risk
Rectocele	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Vulva cyst	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Tachycardia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0008 affected243 at risk EG0012 affected109 at risk
Palpitations	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0003 affected243 at risk EG0012 affected109 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0003 affected243 at risk EG0012 affected109 at risk
Arrhythmia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0004 affected243 at risk EG0010 affected109 at risk
Ear pain	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0011 affected109 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0012 affected109 at risk
Deafness	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Ear discomfort	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0011 affected109 at risk
Hypoacusis	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Hepatotoxicity	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0011 affected109 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected243 at risk EG0011 affected109 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Hepatic pain	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0011 affected109 at risk
Hypertransaminasaemia	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0011 affected109 at risk
Acrochordon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Malignant ascites	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Seborrhoeic keratosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Lymphangiosis carcinomatosa	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Hypersensitivity	Immune system disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0011 affected109 at risk
Infusion related reaction	Immune system disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Contrast media allergy	Immune system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Food allergy	Immune system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Seasonal allergy	Immune system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk
Hyperparathyroidism secondary	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Hypothyroidism	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Device dislocation	Product Issues	MedDRA 21.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected109 at risk
Wound drainage	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected109 at risk

Ancestor Terms

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D010049	Ovarian Diseases
D000291	Adnexal Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D000091662	Genital Diseases
D004700	Endocrine System Diseases
D006058	Gonadal Disorders
D005184	Fallopian Tube Diseases

ID	Term
D000077216	Carcinoma, Ovarian Epithelial
D005185	Fallopian Tube Neoplasms
D010051	Ovarian Neoplasms

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes
D002166	Camptothecin
D000470	Alkaloids
D006571	Heterocyclic Compounds

ID	Term
C000607289	mirvetuximab soravtansine
D017239	Paclitaxel
C506643	liposomal doxorubicin
D019772	Topotecan