A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors | NCT04032704

Name	Class
Merck Sharp & Dohme LLC	INDUSTRY

Label	Type	Description	Intervention Names
Part A: Non-randomized LV monotherapy	Experimental	Monotherapy dosing schedule 1.	Drug: ladiratuzumab vedotin
Part B: Non-randomized LV monotherapy	Experimental	Monotherapy dosing schedule 2.	Drug: ladiratuzumab vedotin
Part C - Arm 1: Randomized LV monotherapy	Experimental	Monotherapy dosing schedule 3.	Drug: ladiratuzumab vedotin
Part C - Arm 2: Randomized LV combination therapy	Experimental	Combination dosing schedule 1.	Drug: ladiratuzumab vedotin Drug: pembrolizumab
Part C - Arm 3: Randomized LV combination therapy	Experimental	Combination dosing schedule 2.	Drug: ladiratuzumab vedotin Drug: pembrolizumab

Name	Type	Description	Arm Group Labels	Other Names
ladiratuzumab vedotin	Drug	Intravenous (into the vein; IV) infusion	Part A: Non-randomized LV monotherapy Part B: Non-randomized LV monotherapy Part C - Arm 1: Randomized LV monotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Part A: Confirmed Objective Response Rate (ORR) as Determined by Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)	Confirmed ORR was defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) per RECIST v.1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to less than (<) 10 millimeter (mm). PR was defined as more than or equal to (>=) 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants who did not have at least 2 post-baseline response assessment (initial response and confirmation scan) were counted as non-responders.	From the first dose of study treatment until the first documented CR or PR or new anticancer therapies or death, whichever occurred first (maximum up to 8.3 months)
Part B: Confirmed ORR as Determined by Investigator According to RECIST v1.1	Confirmed ORR was defined as the percentage of participants with a confirmed CR or PR per RECIST v.1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. PR was defined as >= 30 % decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants who did not have at least 2 post-baseline response assessment (initial response and confirmation scan) were counted as non-responders.	From the first dose of study treatment until the first documented CR or PR or new anticancer therapies or death, whichever occurred first (maximum up to 34.7 months for 1.25 mg/kg and 5.7 months for 1 mg/kg dose level)
Part B: Confirmed Prostate-Specific Antigen (PSA) Response Rate as Determined by Investigator According to Prostate Cancer Clinical Trials Working Group 3 (PCWG3) Criteria, for Prostate Cancer	Confirmed PSA response rate was defined as the percentage of participants with a reduction from baseline PSA level of at least 50%, measured twice >= 3 weeks apart. PSA progression was defined as per PCWG3 criteria- a) if a participant presented first a decline from baseline, progression was defined as the first PSA increase that was >=25% and >=2 nanograms per milliliter (ng/mL) above the nadir, and which was confirmed by a consecutive second value >=3 weeks later that fulfilled the same criteria (that is, a confirmed rising trend); b) if a participant did not present a decline from baseline, progression was defined as the first PSA increase that was >=25% and >=2 ng/mL increased from baseline beyond 12 weeks.

Secondary Outcomes

Measure	Description	Time Frame
Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Treatment Related TEAEs and >= Grade 3 TEAE	An adverse event (AE) was any untoward medical occurrence in a participant/ clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. AEs included both SAEs ad all non-SAEs. TEAEs were defined as newly occurring (not present at baseline)/worsening after first dose of study treatment. TESAEs were any untoward medical occurrence at any dose that: suspected to cause death; life-threatening; required hospitalization; persistent/significant disability/incapacity & may cause congenital anomaly/birth defect. Treatment related TEAEs were related to study treatment and relatedness was judged by investigator. TEAEs were graded according to National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version (v) 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening).

Eligibility Module

Eligibility Criteria

Inclusion Criteria

All Cohorts
- Measurable disease according to RECIST v1.1 as assessed by the investigator
- Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1
Cohort 1: SCLC (Parts A and B)
- Must have extensive stage disease
- Must have disease progression during or following prior platinum-based systemic chemotherapy for extensive stage disease;
- No more than 1 prior line of cytotoxic chemotherapy for extensive disease stage
- May have received prior anti-PD(L)1 therapy
Cohort 2: NSCLC-squamous (Parts A and B)
- Must have unresectable locally advanced or metastatic disease
- Must have disease progression during or following systemic therapy
  - Participants must have progressed during or after a platinum-based combination therapy administered for the treatment of metastatic disease, OR
  - Participants must have progressed within 6 months of last dose of platinum-based adjuvant, neoadjuvant, or definitive chemotherapy, or concomitant chemoradiation regimen for early stage or locally advanced stage disease.
- Participants with known epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), reactive oxygen species (ROS), BRAF, or other actionable mutations are not eligible
- No more than 1 prior line of cytotoxic chemotherapy for their advanced disease
- Must have received prior anti-PD(L)1 therapy, unless contraindicated
Cohort 3: NSCLC-nonsquamous (Parts A and B)
- Must have unresectable locally advanced or metastatic disease
- Must have disease progression during or following systemic therapy
  - Participants must have progressed during or after a platinum-based combination therapy administered for the treatment of metastatic disease, OR
  - Participants must have progressed within 6 months of last dose of platinum-based adjuvant, neoadjuvant, or definitive chemotherapy, or concomitant chemoradiation regimen for early stage or locally advanced state disease.
- Participants with known EGFR, ALK, ROS, BRAF, tropomyosin receptor kinase (TRK), or other actionable mutations are not eligible
- Must have had prior platinum-based chemotherapy
- No more than 1 prior line of cytotoxic chemotherapy for their advanced disease
- Must have received prior anti-PD(L)1 therapy, unless contraindicated
Cohort 4: HNSCC (Parts A and B)
- Must have unresectable locally recurrent or metastatic disease
  - Must have disease progression during or following prior line of systemic therapy
  - Disease progression after treatment with a platinum-containing regimen for recurrent/metastatic disease; OR
  - Recurrence/progression within 6 months of last dose of platinum therapy given as part of a multimodal therapy in the curative setting
- No more than 1 line of cytotoxic chemotherapy for their advanced disease
- May have received prior anti-PD(L)1 therapy, unless contraindicated
Cohort 5: esophageal-squamous (Parts A and B)
- Must have unresectable locally advanced or metastatic disease
- Must have disease progression during or following systemic therapy
- Must have had prior platinum-based chemotherapy
- No more than 1 line of cytotoxic chemotherapy for their advanced disease
Cohort 6: gastric and GEJ adenocarcinoma (Parts A and B)
- Must have unresectable locally advanced or metastatic disease
- Must have received prior platinum-based therapy
- Must have disease progression during or following systemic therapy
- Participants with known human epidermal growth factor receptor 2 (HER2) overexpression must have received prior HER2-targeted therapy
- No more than 1 line of prior cytotoxic chemotherapy for their advanced disease
- Participants may have received prior anti-PD(L)1 therapy, unless contraindicated
Cohort 7: CRPC (Part B only)
- Must have histologically or cytologically confirmed adenocarcinoma of the prostate
  - Participants with components of small cell of neuroendocrine histology are excluded
- Must have metastatic castration-resistant disease
- Must have been ≥28 days between cessation of androgen receptor-targeted therapy and start of study treatment
- Must have received no more than 1 prior line of androgen receptor-targeted therapy for metastatic castration-sensitive prostate cancer or CRPC
- No prior cytotoxic chemotherapy in the metastatic CRPC setting
  - For participants who received cytotoxic chemotherapy in CSPC, at least 6 months must have elapsed between last dose of chemotherapy and start of study treatment
  - No more than 1 prior line of cytotoxic chemotherapy for CSPC
- Participants with measurable disease are eligible if the following criteria are met:
  - A minimum starting PSA level ≥1.0 ng/mL
  - Participants with measurable soft tissue disease must have evidence of measurable soft tissue disease according to PCWG3 criteria.
- Participants with known breast cancer gene (BRCA) mutations are excluded
- No prior radioisotope therapy or radiotherapy to ≥30% of bone marrow
Cohort 8: Melanoma (Parts B and C)
- Must have histologically or cytologically confirmed cutaneous malignant melanoma
  - Participants with mucosal, acral, or uveal melanoma are excluded
- Must have locally advanced unresectable or metastatic stage disease
- Must have progressive disease following anti-PD(L)1 therapy
- Must have received BRAF +/- MEK inhibitor therapy if BRAF mutated (Part C)

Exclusion Criteria

Active concurrent malignancy or a previous malignancy within the past 3 years
Any anticancer therapy within 3 weeks of starting study treatment. Participants who are/were on adjuvant hormonal therapy for the treatment of malignancies with negligible risk of metastases are eligible.
Known active central nervous system lesions
Any ongoing clinically significant toxicity associated with prior treatment (Grade 2 or higher)
Ongoing sensory or motor neuropathy of Grade ≥2
Has received prior radiotherapy within 2 weeks of start of study treatment
History of interstitial lung disease.

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Ironwood Cancer & Research Centers - Chandler		Chandler	Arizona	85224	United States
Adventist Health White Memorial

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Part A: Cohort 1, LV 2.5 mg/kg	Participants with SCLC were administered ladiratuzumab vedotin (LV) 2.5 milligram per kilogram (mg/kg) as intravenous (IV) fusion on Day 1 of each 21-day cycle (q3wk) .
FG001	Part A: Cohort 2, LV 2.5 mg/kg

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
Prot	Yes	No	No	Study Protocol	Nov 2, 2022	Nov 12, 2024

Arm/Group Information

ID	Title	Description
BG000	Part A: Cohort 1, LV 2.5 mg/kg	Participants with SCLC were administered ladiratuzumab vedotin (LV) 2.5 milligram per kilogram (mg/kg) as intravenous (IV) fusion on Day 1 of each 21-day cycle (q3wk).
BG001	Part A: Cohort 2, LV 2.5 mg/kg	Participants with NSCLC-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.
BG002	Part A: Cohort 3, LV 2.5 mg/kg	Participants with NSCLC-nonsquamous were administered LV 2.5 mg/kg as IV fusion q3wk.
BG003	Part A: Cohort 4, LV 2.5 mg/kg	Participants with HNSCC were administered LV 2.5 mg/kg as IV fusion q3wk.
BG004	Part A: Cohort 5, LV 2.5 mg/kg	Participants with esophageal-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.
BG005	Part A: Cohort 6, LV 2.5 mg/kg	Participants with GEJ were administered LV 2.5 mg/kg as IV fusion q3wk.
BG006	Part B: Cohort 1, LV 1.25 mg/kg	Participants with SCLC were administered LV 1.25 mg/kg on Days 1, 8 and 15 of each 21-day cycle (q1wk) as a 30-minute IV infusion.
BG007	Part B: Cohort 2, LV 1.25 mg/kg	Participants with NSCLC-squamous were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.
BG008	Part B: Cohort 3, LV 1.25 mg/kg	Participants with NSCLC-nonsquamous were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.
BG009	Part B: Cohort 4, LV 1.25 mg/kg	Participants with HNSCC were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.
BG010	Part B: Cohort 5, LV 1.25 mg/kg	Participants with esophageal-squamous were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.
BG011	Part B: Cohort 6, LV 1.25 mg/kg	Participants with GEJ were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.
BG012	Part B: Cohort 7, LV 1.25 mg/kg	Participants with CRPC were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.
BG013	Part B: Cohort 8, LV 1.25 mg/kg	Participants with melanoma were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.
BG014	Part B: Cohort 1, LV 1.0 mg/kg	Participants with SCLC were administered LV 1.0 mg/kg q1wk on Days 1, 8 and 15 as a 30-minute IV infusion.
BG015	Part B: Cohort 3, LV 1.0 mg/kg	Participants with NSCLC-nonsquamous were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.
BG016	Part B: Cohort 4, LV 1.0 mg/kg	Participants with HNSCC were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.
BG017	Part B: Cohort 6, LV 1.0 mg/kg	Participants with GEJ were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.
BG018	Total	Total of all reporting groups

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

Part A: Confirmed Objective Response Rate (ORR) as Determined by Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

Confirmed ORR was defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) per RECIST v.1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to less than (<) 10 millimeter (mm). PR was defined as more than or equal to (>=) 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants who did not have at least 2 post-baseline response assessment (initial response and confirmation scan) were counted as non-responders.

The full analysis set (FAS) included all participants who received any amount of study drug.

Posted

Number

95% Confidence Interval

Percentage of participants

From the first dose of study treatment until the first documented CR or PR or new anticancer therapies or death, whichever occurred first (maximum up to 8.3 months)

ID	Title	Description
OG000	Part A: Cohort 1, LV 2.5 mg/kg	Participants with SCLC were administered ladiratuzumab vedotin (LV) 2.5 milligram per kilogram (mg/kg) as intravenous (IV) fusion on Day 1 of each 21-day cycle (q3wk).
OG001	Part A: Cohort 2, LV 2.5 mg/kg	Participants with NSCLC-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.
OG002	Part A: Cohort 3, LV 2.5 mg/kg	Participants with NSCLC-nonsquamous were administered LV 2.5 mg/kg as IV fusion q3wk.
OG003	Part A: Cohort 4, LV 2.5 mg/kg	Participants with HNSCC were administered LV 2.5 mg/kg as IV fusion q3wk.
OG004	Part A: Cohort 5, LV 2.5 mg/kg	Participants with esophageal-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.
OG005	Part A: Cohort 6, LV 2.5 mg/kg	Participants with GEJ were administered LV 2.5 mg/kg as IV fusion q3wk.

Units	Counts
Participants	OG00010 OG0012 OG00213 OG003

Title

Denominators

Categories

Title	Measurements
	OG00010(0.3 to 44.5) OG0010(0.0 to 84.2) OG0028(0.2 to 36.0) OG003

Primary

Part B: Confirmed ORR as Determined by Investigator According to RECIST v1.1

Confirmed ORR was defined as the percentage of participants with a confirmed CR or PR per RECIST v.1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. PR was defined as >= 30 % decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants who did not have at least 2 post-baseline response assessment (initial response and confirmation scan) were counted as non-responders.

The FAS included all participants who received any amount of study drug. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Posted

Number

95% Confidence Interval

Percentage of participants

From the first dose of study treatment until the first documented CR or PR or new anticancer therapies or death, whichever occurred first (maximum up to 34.7 months for 1.25 mg/kg and 5.7 months for 1 mg/kg dose level)

ID	Title	Description
OG000	Part B: Cohort 1, LV 1.25 mg/kg	Participants with SCLC were administered LV 1.25 mg/kg on Days 1, 8 and 15 of each 21-day cycle (q1wk) as a 30-minute IV infusion.
OG001	Part B: Cohort 2, LV 1.25 mg/kg	Participants with NSCLC-squamous were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.

Primary

Part B: Confirmed Prostate-Specific Antigen (PSA) Response Rate as Determined by Investigator According to Prostate Cancer Clinical Trials Working Group 3 (PCWG3) Criteria, for Prostate Cancer

Confirmed PSA response rate was defined as the percentage of participants with a reduction from baseline PSA level of at least 50%, measured twice >= 3 weeks apart. PSA progression was defined as per PCWG3 criteria- a) if a participant presented first a decline from baseline, progression was defined as the first PSA increase that was >=25% and >=2 nanograms per milliliter (ng/mL) above the nadir, and which was confirmed by a consecutive second value >=3 weeks later that fulfilled the same criteria (that is, a confirmed rising trend); b) if a participant did not present a decline from baseline, progression was defined as the first PSA increase that was >=25% and >=2 ng/mL increased from baseline beyond 12 weeks.

The FAS included all participants who received any amount of study drug. As prespecified in protocol, this outcome measure was planned to be analyzed only in the Part B: Cohort 7, LV 1.25 mg/kg arm. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Posted

Number

95% Confidence Interval

Percentage of participants

From the first dose of study treatment up to the date of last response assessment (maximum up to 13.5 months)

ID	Title	Description
OG000	Part B: Cohort 7, LV 1.25 mg/kg	Participants with CRPC were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.

Secondary

Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Treatment Related TEAEs and >= Grade 3 TEAE

An adverse event (AE) was any untoward medical occurrence in a participant/ clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. AEs included both SAEs ad all non-SAEs. TEAEs were defined as newly occurring (not present at baseline)/worsening after first dose of study treatment. TESAEs were any untoward medical occurrence at any dose that: suspected to cause death; life-threatening; required hospitalization; persistent/significant disability/incapacity & may cause congenital anomaly/birth defect. Treatment related TEAEs were related to study treatment and relatedness was judged by investigator. TEAEs were graded according to National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version (v) 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening).

The safety analysis set included all participants who received any amount of study drug.

Posted

Count of Participants

Participants

From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months)

ID	Title	Description
OG000	Part A: Cohort 1, LV 2.5 mg/kg	Participants with SCLC were administered ladiratuzumab vedotin (LV) 2.5 milligram per kilogram (mg/kg) as intravenous (IV) fusion on Day 1 of each 21-day cycle (q3wk).
OG001

Secondary

Part B: Number of Participants With TEAEs, TESAEs, Treatment Related TEAEs and >= Grade 3 TEAE

An AE was any untoward medical occurrence in a participant, or a clinical investigational participant administered a medicinal product, and which does not necessarily have a causal relationship with this treatment. AEs included both SAEs ad all non-SAEs. TEAEs were defined as newly occurring (not present at baseline) or worsening after first dose of study treatment. TESAEs were any untoward medical occurrence at any dose that: suspected to cause death; life-threatening; required hospitalization; persistent or significant disability or incapacity and may cause congenital anomaly or birth defect. Treatment related TEAEs were related to study treatment and relatedness was judged by investigator. TEAEs were graded according to NCI-CTCAE v4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening).

The safety analysis set included all participants who received any amount of study drug.

Posted

Count of Participants

Participants

From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months)

ID	Title	Description
OG000	Part B: Cohort 1, LV 1.25 mg/kg	Participants with SCLC were administered LV 1.25 mg/kg on Days 1, 8 and 15 of each 21-day cycle (q1wk) as a 30-minute IV infusion.
OG001	Part B: Cohort 2, LV 1.25 mg/kg	Participants with NSCLC-squamous were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.

Secondary

Part A: Confirmed Investigator Determined Disease Control Rate (DCR) According to RECIST v1.1

DCR was defined as percentage of participants who achieved confirmed and unconfirmed CR or PR per RECIST v1.1 or met stable disease (SD) criteria at least once after start of study treatment at minimum interval of 5 weeks. CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR was defined as >= 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference smallest sum diameters while on study. PD: at least 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study (this included baseline sum if that is smallest on study). In addition to relative increase of 20%, sum must also demonstrate an absolute increase of at least 0.5 cm. Appearance of one or more new lesions was also considered progression.

The FAS included all participants who received any amount of study drug.

Posted

Number

95% Confidence Interval

Percentage of participants

From the first dose of study treatment until the first documented CR, PR or SD or new anticancer therapies or death, whichever occurred first (maximum up to 4.1 months)

ID	Title	Description
OG000	Part A: Cohort 1, LV 2.5 mg/kg	Participants with SCLC were administered ladiratuzumab vedotin (LV) 2.5 milligram per kilogram (mg/kg) as intravenous (IV) fusion on Day 1 of each 21-day cycle (q3wk).

Secondary

Part B: Confirmed Investigator Determined DCR According to RECIST v1.1

DCR was defined as percentage of participants who achieved confirmed and unconfirmed CR or PR per RECIST v1.1 or met SD criteria at least once after start of study treatment at a minimum interval of 5 weeks. CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR was defined as >= 30 % decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: At least 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 0.5 centimeter (cm). Appearance of one or more new lesions was also considered progression.

The FAS included all participants who received any amount of study drug. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Posted

Number

95% Confidence Interval

Percentage of participants

From the first dose of study treatment until the first documented CR, PR or SD or new anticancer therapies or death, whichever occurred first (maximum up to 5.5 months for 1.25 mg/kg and 1.5 months for 1 mg/kg dose level)

ID	Title	Description
OG000	Part B: Cohort 1, LV 1.25 mg/kg	Participants with SCLC were administered LV 1.25 mg/kg on Days 1, 8 and 15 of each 21-day cycle (q1wk) as a 30-minute IV infusion.

Secondary

Part A: Confirmed Investigator Determined Duration of Response (DOR) According to RECIST v1.1

DOR:time from 1st documentation of OR(confirmed CR/PR per RECIST Version 1.1) to 1st documentation of PD/death due to any cause,whichever occurred first.CR:disappearance of all target lesions.Any pathological lymph nodes must have reduction in short axis to <10 mm.PR:>=30 % decrease in sum of diameters of target lesions, taking as reference baseline sum diameters. Participants do not have PD and are still on study at time of analysis/are removed from study prior to documentation of PD were censored at last disease assessment documenting absence of PD. Participants who started new anticancer treatment prior to documentation of PD were censored at last disease assessment prior to start of new treatment.PD:at least 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study.In addition to relative increase of 20%, sum must demonstrate absolute increase of 0.5 cm.Appearance of one/more new lesions was considered progression. Kaplan-Meier method was used.

Posted

Median

95% Confidence Interval

Months

From the first documentation of CR or PR to PD or death or censoring whichever occurred first (maximum up to 5.7 months)

ID	Title	Description
OG000	Part A: Cohort 1, LV 2.5 mg/kg	Participants with SCLC were administered ladiratuzumab vedotin (LV) 2.5 milligram per kilogram (mg/kg) as intravenous (IV) fusion on Day 1 of each 21-day cycle (q3wk).

Secondary

Part B: Confirmed Investigator Determined DOR According to RECIST v1.1

The FAS included all participants who received any amount of study drug. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure. No participant had CR or PR in Part B: Cohort 4, LV 1.25 mg/kg arm, Part B: Cohort 7, LV 1.25 mg/kg arm, Part B: Cohort 1, LV 1.0 mg/kg arm, Part B: Cohort 3, LV 1.0 mg/kg arm and Part B: Cohort 4, LV 1.0 mg/kg arm.

Posted

Median

95% Confidence Interval

Months

From the first documentation of CR or PR to PD or death or censoring whichever occurred first (maximum up to 32.0 months for 1.25 mg/kg and 4.2 months for 1 mg/kg dose level)

ID	Title	Description
OG000	Part B: Cohort 1, LV 1.25 mg/kg

Secondary

Part B: Confirmed Investigator Determined PSA-DOR, for Prostate Cancer

PSA-DOR was defined as the time from the first documentation of PSA response (subsequently confirmed at least 3 weeks apart) to the first documentation of PSA progression or death due to any cause, whichever occurred first. Confirmed PSA response rate was defined as the percentage of participants with a reduction from baseline PSA level of at least 50%, measured twice >= 3 weeks apart. Participants who do not have PD and are still on study at the time of an analysis or who are removed from the study prior to documentation of PD was censored at the date of last disease assessment documenting absence of PD. Participants who started a new anticancer treatment prior to documentation of PD were censored at the date of last disease assessment prior to the start of new treatment. The confidence interval (CI) was calculated using the complementary log-log transformation method.

Posted

Median

95% Confidence Interval

Months

From the first documentation of CR or PR to PD or death or censoring whichever occurred first (maximum up to 3 months)

ID	Title	Description
OG000	Part B: Cohort 7, LV 1.25 mg/kg	Participants with CRPC were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.

Secondary

Part A: Confirmed Investigator Determined Progression Free Survival (PFS) According to RECIST v1.1

PFS: time from start of study treatment to the first documentation of PD by RECIST v1.1 or clinical PD. Participants who do not have PD and are still on study at the time of an analysis or who are removed from the study prior to documentation of PD were censored at the date of last disease assessment documenting absence of PD. Participants who started a new anticancer treatment prior to documentation of PD were censored at the date of last disease assessment prior to the start of new treatment. PD: At least 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 0.5 cm. Appearance of one or more new lesions was also considered progression. Median was estimated using the Kaplan-Meier method and the CI was calculated using the complementary log-log transformation method.

The FAS included all participants who received any amount of study drug.

Posted

Median

95% Confidence Interval

Months

From first dose of study treatment to the date of PD or clinical PD or censoring whichever occurred first (maximum up to 8.3 months)

ID	Title	Description
OG000	Part A: Cohort 1, LV 2.5 mg/kg	Participants with SCLC were administered ladiratuzumab vedotin (LV) 2.5 milligram per kilogram (mg/kg) as intravenous (IV) fusion on Day 1 of each 21-day cycle (q3wk).
OG001

Secondary

Part B: Confirmed Investigator Determined PFS According to RECIST v1.1

The FAS included all participants who received any amount of study drug. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Posted

Median

95% Confidence Interval

Months

From first dose of study treatment to the date of PD or clinical PD or censoring whichever occurred first (maximum up to 34.7 months for 1.25 mg/kg and 5.7 months for 1 mg/kg dose level)

ID	Title	Description
OG000	Part B: Cohort 1, LV 1.25 mg/kg	Participants with SCLC were administered LV 1.25 mg/kg on Days 1, 8 and 15 of each 21-day cycle (q1wk) as a 30-minute IV infusion.

Secondary

Part B: Confirmed Investigator Determined PSA-PFS, for Prostate Cancer

PSA-PFS: time from start of study treatment to first documentation of PSA progression or death due to any cause, whichever occurred first. Participants who do not have PD and are still on study at time of analysis or who are removed from study prior to documentation of PD was censored at date of last disease assessment documenting absence of PD. Participants who started new anticancer treatment prior to documentation of PD were censored at date of last disease assessment prior to the start of new treatment. PD: at least 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study (this included baseline sum if that is smallest on study). In addition to relative increase of 20%, sum must also demonstrate absolute increase of at least 0.5 cm. Appearance of one or more new lesions was also considered progression. Median was estimated using Kaplan-Meier method and CI was calculated using the complementary log-log transformation method.

Posted

Median

95% Confidence Interval

Months

From first dose of study treatment to the date of PD or clinical PD or censoring whichever occurred first (maximum up to 5.7 months)

ID	Title	Description
OG000	Part B: Cohort 7, LV 1.25 mg/kg	Participants with CRPC were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.

Secondary

Part A: Overall Survival (OS)

OS was defined as the time from the start of study treatment to date of death due to any cause. Participants who do not have PD and are still on study at the time of an analysis or who are removed from the study prior to documentation of PD was censored at the date of last disease assessment documenting absence of PD. Participants who started a new anticancer treatment prior to documentation of PD were censored at the date of last disease assessment prior to the start of new treatment. Median was estimated using the Kaplan-Meier method.

The FAS included all participants who received any amount of study drug.

Posted

Median

95% Confidence Interval

Months

From first dose of study treatment to the date of death or censoring whichever occurred first (maximum up to 27.5 months)

ID	Title	Description
OG000	Part A: Cohort 1, LV 2.5 mg/kg	Participants with SCLC were administered ladiratuzumab vedotin (LV) 2.5 milligram per kilogram (mg/kg) as intravenous (IV) fusion on Day 1 of each 21-day cycle (q3wk).
OG001	Part A: Cohort 2, LV 2.5 mg/kg	Participants with NSCLC-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.
OG002	Part A: Cohort 3, LV 2.5 mg/kg

Secondary

Part B: Overall Survival

The FAS included all participants who received any amount of study drug.

Posted

Median

95% Confidence Interval

Months

From first dose of study treatment to the date of death or censoring whichever occurred first (maximum up to 37.5 months for 1.25 mg/kg and 20.9 months for 1 mg/kg dose level)

ID	Title	Description
OG000	Part B: Cohort 1, LV 1.25 mg/kg	Participants with SCLC were administered LV 1.25 mg/kg on Days 1, 8 and 15 of each 21-day cycle (q1wk) as a 30-minute IV infusion.
OG001	Part B: Cohort 2, LV 1.25 mg/kg	Participants with NSCLC-squamous were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.
OG002	Part B: Cohort 3, LV 1.25 mg/kg

Secondary

Part A: Area Under the Serum Concentration Time Curve Between Days 0 to 21 (AUC21) of Ladiratuzumab Vedotin

Area under the observed concentration-time curve from the time of dosing to Day 21 of LV was calculated by noncompartmental analysis.

The safety analysis set included all participants who received any amount of study drug. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Posted

Geometric Mean

Geometric Coefficient of Variation

Day*micrograms per milliliter

AUC21 is reported on Day 21 using PK concentrations assessed at Pre-dose, end of infusion, 2 hour, 4 hour, 48 hour, 168 hour and 336 hour post dose of Cycle 1 (each cycle = 21 days, LV administered on Day 1 of cycle)

ID	Title	Description
OG000	Part A: Cohort 1, LV 2.5 mg/kg	Participants with SCLC were administered ladiratuzumab vedotin (LV) 2.5 milligram per kilogram (mg/kg) as intravenous (IV) fusion on Day 1 of each 21-day cycle (q3wk).
OG001	Part A: Cohort 2, LV 2.5 mg/kg	Participants with NSCLC-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.
OG002	Part A: Cohort 3, LV 2.5 mg/kg	Participants with NSCLC-nonsquamous were administered LV 2.5 mg/kg as IV fusion q3wk.

Secondary

Part A: Maximum Serum Concentration (Cmax) According to Antibody-Drug Conjugate (ADC) Pharmacokinetic Parameters

Cmax according to ADC pharmacokinetic parameters was reported.

The safety analysis set included all participants who received any amount of study drug.

Posted

Geometric Mean

Geometric Coefficient of Variation

Micrograms per milliliter

Cmax during Day 1 to 21 post LV administration on Day 1 was reported using PK concentration assessed at Pre-dose, end of infusion, 2 hour, 4 hour, 48 hour, 168 hour and 336 hour post-dose of LV administration on Day 1 (each cycle = 21 days)

ID	Title	Description
OG000	Part A: Cohort 1, LV 2.5 mg/kg	Participants with SCLC were administered ladiratuzumab vedotin (LV) 2.5 milligram per kilogram (mg/kg) as intravenous (IV) fusion on Day 1 of each 21-day cycle (q3wk).
OG001	Part A: Cohort 2, LV 2.5 mg/kg	Participants with NSCLC-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.
OG002	Part A: Cohort 3, LV 2.5 mg/kg	Participants with NSCLC-nonsquamous were administered LV 2.5 mg/kg as IV fusion q3wk.
OG003

Secondary

Part A: AUC21 of Total Antibody (TAB)

Area under the observed concentration-time curve from the time of dosing to Day 21 of TAB was calculated by noncompartmental analysis.

The safety analysis set included all participants who received any amount of study drug. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Posted

Geometric Mean

Geometric Coefficient of Variation

Day*micrograms per milliliter

ID	Title	Description
OG000	Part A: Cohort 1, LV 2.5 mg/kg	Participants with SCLC were administered ladiratuzumab vedotin (LV) 2.5 milligram per kilogram (mg/kg) as intravenous (IV) fusion on Day 1 of each 21-day cycle (q3wk).
OG001	Part A: Cohort 2, LV 2.5 mg/kg	Participants with NSCLC-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.
OG002	Part A: Cohort 3, LV 2.5 mg/kg	Participants with NSCLC-nonsquamous were administered LV 2.5 mg/kg as IV fusion q3wk.

Secondary

Part A: Cmax According to TAB Pharmacokinetic Parameters

Cmax according to TAB pharmacokinetic parameters was reported.

The safety analysis set included all participants who received any amount of study drug. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Posted

Geometric Mean

Geometric Coefficient of Variation

Micrograms per milliliter

ID	Title	Description
OG000	Part A: Cohort 1, LV 2.5 mg/kg	Participants with SCLC were administered ladiratuzumab vedotin (LV) 2.5 milligram per kilogram (mg/kg) as intravenous (IV) fusion on Day 1 of each 21-day cycle (q3wk).
OG001	Part A: Cohort 2, LV 2.5 mg/kg	Participants with NSCLC-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.
OG002	Part A: Cohort 3, LV 2.5 mg/kg	Participants with NSCLC-nonsquamous were administered LV 2.5 mg/kg as IV fusion q3wk.

Secondary

Part A: AUC21 of Monomethyl Auristatin E (MMAE)

Area under the observed concentration-time curve from the time of dosing to Day 21 of MMAE was calculated by noncompartmental analysis.

The safety analysis set included all participants who received any amount of study drug. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Posted

Geometric Mean

Geometric Coefficient of Variation

Day*nanogram per milliliter

ID	Title	Description
OG000	Part A: Cohort 1, LV 2.5 mg/kg	Participants with SCLC were administered ladiratuzumab vedotin (LV) 2.5 milligram per kilogram (mg/kg) as intravenous (IV) fusion on Day 1 of each 21-day cycle (q3wk).
OG001	Part A: Cohort 2, LV 2.5 mg/kg	Participants with NSCLC-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.
OG002	Part A: Cohort 3, LV 2.5 mg/kg	Participants with NSCLC-nonsquamous were administered LV 2.5 mg/kg as IV fusion q3wk.

Secondary

Part A: Cmax According to MMAE Pharmacokinetic Parameters

Cmax according to MMAE pharmacokinetic parameters was reported.

The safety analysis set included all participants who received any amount of study drug. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Posted

Geometric Mean

Geometric Coefficient of Variation

Nanogram per milliliter

ID	Title	Description
OG000	Part A: Cohort 1, LV 2.5 mg/kg	Participants with SCLC were administered ladiratuzumab vedotin (LV) 2.5 milligram per kilogram (mg/kg) as intravenous (IV) fusion on Day 1 of each 21-day cycle (q3wk).
OG001	Part A: Cohort 2, LV 2.5 mg/kg	Participants with NSCLC-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.
OG002	Part A: Cohort 3, LV 2.5 mg/kg	Participants with NSCLC-nonsquamous were administered LV 2.5 mg/kg as IV fusion q3wk.

Secondary

Part B: Area Under the Concentration Time Curve Between Day 0 to 7 (AUC7) of ADC

Area under the observed concentration-time curve from the time of dosing to Day 7 of ADC was calculated by noncompartmental analysis.

The safety analysis set included all participants who received any amount of study drug. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure. There were insufficient samples to provide pharmacokinetic (PK) estimates for analytes in Part B: Cohort 6, LV 1.0 mg/kg arm.

Posted

Geometric Mean

Geometric Coefficient of Variation

Day*micrograms per milliliter

AUC7 is reported at Day 7 using PK concentration assessed at Pre-dose, end of infusion, 2hr, 4hr, 48hr post-dose of LV administration on Day 1; pre-dose PK concentration on Day 8 in Cycle 1 (each cycle=21 days, LV administered on Day 1, 8 and 15 of cycle)

ID	Title	Description
OG000	Part B: Cohort 1, LV 1.25 mg/kg	Participants with SCLC were administered LV 1.25 mg/kg on Days 1, 8 and 15 of each 21-day cycle (q1wk) as a 30-minute IV infusion.
OG001	Part B: Cohort 2, LV 1.25 mg/kg	Participants with NSCLC-squamous were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.
OG002	Part B: Cohort 3, LV 1.25 mg/kg

Secondary

Part B: Cmax According to ADC Pharmacokinetic Parameters

Cmax according to ADC pharmacokinetic parameters was reported.

The safety analysis set included all participants who received any amount of study drug. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure. There were insufficient samples to provide PK estimates for analytes in Part B: Cohort 6, LV 1.0 mg/kg arm.

Posted

Geometric Mean

Geometric Coefficient of Variation

Micrograms per milliliter

Cmax during Day 1 to 7 post LV administration on Day 1 was reported using PK concentration assessed at Pre-dose, end of infusion, 2 hr, 4 hr, 48 hr post-dose of LV administration on Day 1 (each cycle = 21 days, LV administered on Day 1, 8 and 15 of cycle)

ID	Title	Description
OG000	Part B: Cohort 1, LV 1.25 mg/kg	Participants with SCLC were administered LV 1.25 mg/kg on Days 1, 8 and 15 of each 21-day cycle (q1wk) as a 30-minute IV infusion.
OG001	Part B: Cohort 2, LV 1.25 mg/kg	Participants with NSCLC-squamous were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.
OG002	Part B: Cohort 3, LV 1.25 mg/kg	Participants with NSCLC-nonsquamous were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.

Secondary

Part B: AUC7 of TAB

Area under the observed concentration-time curve from the time of dosing to Day 7of TAB was calculated by noncompartmental analysis.

The safety analysis set included all participants who received any amount of study drug. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure. There were insufficient samples to provide PK estimates for analytes in Part B: Cohort 6, LV 1.0 mg/kg arm.

Posted

Geometric Mean

Geometric Coefficient of Variation

Day*micrograms per milliliter

ID	Title	Description
OG000	Part B: Cohort 1, LV 1.25 mg/kg	Participants with SCLC were administered LV 1.25 mg/kg on Days 1, 8 and 15 of each 21-day cycle (q1wk) as a 30-minute IV infusion.
OG001	Part B: Cohort 2, LV 1.25 mg/kg	Participants with NSCLC-squamous were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.
OG002	Part B: Cohort 3, LV 1.25 mg/kg	Participants with NSCLC-nonsquamous were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.

Secondary

Part B: Cmax According to TAB Pharmacokinetic Parameters

Cmax according to TAB pharmacokinetic parameters was reported.

The safety analysis set included all participants who received any amount of study drug. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure. There were insufficient samples to provide PK estimates for analytes in Part B: Cohort 6, LV 1.0 mg/kg arm.

Posted

Geometric Mean

Geometric Coefficient of Variation

Micrograms per milliliter

ID	Title	Description
OG000	Part B: Cohort 1, LV 1.25 mg/kg	Participants with SCLC were administered LV 1.25 mg/kg on Days 1, 8 and 15 of each 21-day cycle (q1wk) as a 30-minute IV infusion.
OG001	Part B: Cohort 2, LV 1.25 mg/kg	Participants with NSCLC-squamous were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.
OG002	Part B: Cohort 3, LV 1.25 mg/kg	Participants with NSCLC-nonsquamous were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.

Secondary

Part B: AUC7 OF MMAE

Area under the observed concentration-time curve from the time of dosing to Day 7 of MMAE was calculated by noncompartmental analysis.

The safety analysis set included all participants who received any amount of study drug. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure. There were insufficient samples to provide PK estimates for analytes in Part B: Cohort 6, LV 1.0 mg/kg arm.

Posted

Geometric Mean

Geometric Coefficient of Variation

Day*micrograms per milliliter

ID	Title	Description
OG000	Part B: Cohort 1, LV 1.25 mg/kg	Participants with SCLC were administered LV 1.25 mg/kg on Days 1, 8 and 15 of each 21-day cycle (q1wk) as a 30-minute IV infusion.
OG001	Part B: Cohort 2, LV 1.25 mg/kg	Participants with NSCLC-squamous were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.
OG002	Part B: Cohort 3, LV 1.25 mg/kg	Participants with NSCLC-nonsquamous were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.

Secondary

Part B: Cmax According to MMAE Pharmacokinetic Parameters

Cmax according to MMAE pharmacokinetic parameters was reported.

The safety analysis set included all participants who received any amount of study drug. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure. There were insufficient samples to provide PK estimates for analytes in Part B: Cohort 6, LV 1.0 mg/kg arm.

Posted

Geometric Mean

Geometric Coefficient of Variation

Nanograms per milliliter

Cmax during Day 1 to 7 post LV administration on Day 1 was reported using PK concentration assessed at Pre-dose, end of infusion, 2 hr, 4 hr, 48 hr post-dose of LV administration on Day 1 (each cycle= 21 days, LV administered on Day 1, 8 and 15 of cycle)

ID	Title	Description
OG000	Part B: Cohort 1, LV 1.25 mg/kg	Participants with SCLC were administered LV 1.25 mg/kg on Days 1, 8 and 15 of each 21-day cycle (q1wk) as a 30-minute IV infusion.
OG001	Part B: Cohort 2, LV 1.25 mg/kg	Participants with NSCLC-squamous were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.
OG002	Part B: Cohort 3, LV 1.25 mg/kg	Participants with NSCLC-nonsquamous were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.

Secondary

Part A: Number of Participants With Positive Post-Baseline Antitherapeutic Antibody (ATA) Incidence

A positive baseline ATA result was considered positive post-baseline if the post-baseline ATA titer result was at least four times higher than the baseline result.

The safety analysis set included all participants who received any amount of study drug. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Posted

Count of Participants

Participants

From first ATA draw to last ATA draw (maximum up to 8.8 months)

ID	Title	Description
OG000	Part A: Cohort 1, LV 2.5 mg/kg	Participants with SCLC were administered ladiratuzumab vedotin (LV) 2.5 milligram per kilogram (mg/kg) as intravenous (IV) fusion on Day 1 of each 21-day cycle (q3wk).
OG001	Part A: Cohort 2, LV 2.5 mg/kg	Participants with NSCLC-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.
OG002	Part A: Cohort 3, LV 2.5 mg/kg	Participants with NSCLC-nonsquamous were administered LV 2.5 mg/kg as IV fusion q3wk.
OG003

Secondary

Part B: Number of Participants With Positive Post-Baseline ATA Incidence

A positive baseline ATA result was considered positive post-baseline if the post-baseline ATA titer result was at least four times higher than the baseline result.

The safety analysis set included all participants who received any amount of study drug. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Posted

Count of Participants

Participants

From first ATA draw to last ATA draw (maximum up to 22.1 months for 1.25 mg/kg and 5.1 months for 1 mg/kg)

ID	Title	Description
OG000	Part B: Cohort 1, LV 1.25 mg/kg	Participants with SCLC were administered LV 1.25 mg/kg on Days 1, 8 and 15 of each 21-day cycle (q1wk) as a 30-minute IV infusion.
OG001	Part B: Cohort 2, LV 1.25 mg/kg	Participants with NSCLC-squamous were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.
OG002	Part B: Cohort 3, LV 1.25 mg/kg	Participants with NSCLC-nonsquamous were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.
OG003

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	Part A: Cohort 1, LV 2.5 mg/kg	Participants with SCLC were administered ladiratuzumab vedotin (LV) 2.5 milligram per kilogram (mg/kg) as intravenous (IV) fusion on Day 1 of each 21-day cycle (q3wk).	9	10	5	10	10	10
EG001	Part A: Cohort 2, LV 2.5 mg/kg	Participants with NSCLC-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	2	2	1	2	2	2
EG002	Part A: Cohort 3, LV 2.5 mg/kg	Participants with NSCLC-nonsquamous were administered LV 2.5 mg/kg as IV fusion q3wk.	10	13	7	13	13	13
EG003	Part A: Cohort 4, LV 2.5 mg/kg	Participants with HNSCC were administered LV 2.5 mg/kg as IV fusion q3wk.	7	7	2	7	6	7
EG004	Part A: Cohort 5, LV 2.5 mg/kg	Participants with esophageal-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	4	5	3	5	5	5
EG005	Part A: Cohort 6, LV 2.5 mg/kg	Participants with GEJ were administered LV 2.5 mg/kg as IV fusion q3wk.	5	12	3	12	12	12
EG006	Part B: Cohort 1, LV 1.25 mg/kg	Participants with SCLC were administered LV 1.25 mg/kg on Days 1, 8 and 15 of each 21-day cycle (q1wk) as a 30-minute IV infusion.	13	16	6	16	15	16
EG007	Part B: Cohort 2, LV 1.25 mg/kg	Participants with NSCLC-squamous were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	13	16	5	16	16	16
EG008	Part B: Cohort 3, LV 1.25 mg/kg	Participants with NSCLC-nonsquamous were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	14	19	9	19	19	19
EG009	Part B: Cohort 4, LV 1.25 mg/kg	Participants with HNSCC were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	12	14	8	14	14	14
EG010	Part B: Cohort 5, LV 1.25 mg/kg	Participants with esophageal-squamous were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	12	17	9	17	17	17
EG011	Part B: Cohort 6, LV 1.25 mg/kg	Participants with GEJ were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	13	21	12	21	19	21
EG012	Part B: Cohort 7, LV 1.25 mg/kg	Participants with CRPC were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	7	13	4	13	13	13
EG013	Part B: Cohort 8, LV 1.25 mg/kg	Participants with melanoma were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	16	30	11	30	30	30
EG014	Part B: Cohort 1, LV 1.0 mg/kg	Participants with SCLC were administered LV 1.0 mg/kg q1wk on Days 1, 8 and 15 as a 30-minute IV infusion.	2	2	1	2	2	2
EG015	Part B: Cohort 3, LV 1.0 mg/kg	Participants with NSCLC-nonsquamous were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	1	2	2	2	2	2
EG016	Part B: Cohort 4, LV 1.0 mg/kg	Participants with HNSCC were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	2	2	1	2	2	2
EG017	Part B: Cohort 6, LV 1.0 mg/kg	Participants with GEJ were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	2	2	0	2	2	2

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG0031 events1 affected7 at risk EG0040 events0 affected5 at risk EG0050 events0 affected12 at risk EG0060 events0 affected16 at risk EG0070 events0 affected16 at risk EG0081 events1 affected19 at risk EG0090 events0 affected14 at risk EG0102 events1 affected17 at risk EG0110 events0 affected21 at risk EG0120 events0 affected13 at risk EG0130 events0 affected30 at risk EG0140 events0 affected2 at risk EG0150 events0 affected2 at risk EG0160 events0 affected2 at risk EG0170 events0 affected2 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA v26.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected2 at risk EG0021 events1 affected13 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	MedDRA v26.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Pericardial effusion	Cardiac disorders	MedDRA v26.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Stress cardiomyopathy	Cardiac disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Laryngocele	Congenital, familial and genetic disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0021 events1 affected13 at risk EG003
Adrenal insufficiency	Endocrine disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Inappropriate antidiuretic hormone secretion	Endocrine disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected2 at risk EG0021 events1 affected13 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Oesophageal fistula	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Oesophageal pain	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Small intestinal perforation	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Asthenia	General disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Complication associated with device	General disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Fatigue	General disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Multiple organ dysfunction syndrome	General disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Oedema peripheral	General disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Pyrexia	General disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Arthritis bacterial	Infections and infestations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Biliary sepsis	Infections and infestations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Biliary tract infection	Infections and infestations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Bronchitis	Infections and infestations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Conjunctivitis bacterial	Infections and infestations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Device related infection	Infections and infestations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Infection	Infections and infestations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Liver abscess	Infections and infestations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Periorbital cellulitis	Infections and infestations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Pneumonia	Infections and infestations	MedDRA v26.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected2 at risk EG0021 events1 affected13 at risk EG003
Pneumonia aspiration	Infections and infestations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Sepsis	Infections and infestations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0021 events1 affected13 at risk EG003
Staphylococcal infection	Infections and infestations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Staphylococcal sepsis	Infections and infestations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Overdose	Injury, poisoning and procedural complications	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Brain natriuretic peptide increased	Investigations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Neutrophil count decreased	Investigations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0021 events1 affected13 at risk EG003
Failure to thrive	Metabolism and nutrition disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA v26.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Mobility decreased	Musculoskeletal and connective tissue disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA v26.1	Systematic Assessment	EG0002 events2 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Lymphangiosis carcinomatosa	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Acute motor-sensory axonal neuropathy	Nervous system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Demyelinating polyneuropathy	Nervous system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Dizziness	Nervous system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0021 events1 affected13 at risk EG003
Encephalopathy	Nervous system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Haemorrhage intracranial	Nervous system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Metabolic encephalopathy	Nervous system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0021 events1 affected13 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Petit mal epilepsy	Nervous system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Seizure	Nervous system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Spinal cord compression	Nervous system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Syncope	Nervous system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0021 events1 affected13 at risk EG003
Vocal cord paralysis	Nervous system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Mental status changes	Psychiatric disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0021 events1 affected13 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0021 events1 affected13 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Bronchial obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected2 at risk EG0021 events1 affected13 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0021 events1 affected13 at risk EG003
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Pharyngeal haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0022 events2 affected13 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected2 at risk EG0020 events0 affected13 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected2 at risk EG0021 events1 affected13 at risk EG003
Erythema multiforme	Skin and subcutaneous tissue disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Hypotension	Vascular disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0022 events2 affected13 at risk EG0031 events1 affected7 at risk EG0041 events1 affected5 at risk EG0053 events2 affected12 at risk EG0063 events2 affected16 at risk EG0070 events0 affected16 at risk EG0083 events2 affected19 at risk EG0092 events2 affected14 at risk EG0104 events2 affected17 at risk EG0118 events6 affected21 at risk EG0121 events1 affected13 at risk EG0138 events7 affected30 at risk EG0140 events0 affected2 at risk EG0150 events0 affected2 at risk EG0161 events1 affected2 at risk EG0171 events1 affected2 at risk
Anaemia macrocytic	Blood and lymphatic system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0021 events1 affected13 at risk EG003
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0021 events1 affected13 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA v26.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA v26.1	Systematic Assessment	EG0002 events2 affected10 at risk EG0010 events0 affected2 at risk EG0021 events1 affected13 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected2 at risk EG0020 events0 affected13 at risk EG003
Palpitations	Cardiac disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Pericardial effusion	Cardiac disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Sinus tachycardia	Cardiac disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0022 events2 affected13 at risk EG003
Tachycardia	Cardiac disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Adrenal insufficiency	Endocrine disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Androgen deficiency	Endocrine disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Hyperprolactinaemia	Endocrine disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Cataract	Eye disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Visual impairment	Eye disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected2 at risk EG0021 events1 affected13 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0003 events3 affected10 at risk EG0010 events0 affected2 at risk EG0021 events1 affected13 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected2 at risk EG0020 events0 affected13 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0021 events1 affected13 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0002 events2 affected10 at risk EG0012 events2 affected2 at risk EG0024 events4 affected13 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0029 events6 affected13 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Gastrointestinal pain	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Haematochezia	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Hiatus hernia	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Melaena	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0006 events3 affected10 at risk EG0011 events1 affected2 at risk EG00210 events8 affected13 at risk EG003
Odynophagia	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Oesophagitis	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Oral pain	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0024 events1 affected13 at risk EG003
Retching	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0021 events1 affected13 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0022 events2 affected13 at risk EG003
Swollen tongue	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Tongue ulceration	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0003 events2 affected10 at risk EG0010 events0 affected2 at risk EG0027 events4 affected13 at risk EG003
Asthenia	General disorders	MedDRA v26.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0011 events1 affected2 at risk EG0022 events2 affected13 at risk EG003
Chest pain	General disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Chills	General disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Face oedema	General disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Fatigue	General disorders	MedDRA v26.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected2 at risk EG00210 events10 affected13 at risk EG003
Gait disturbance	General disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0021 events1 affected13 at risk EG003
Influenza like illness	General disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0021 events1 affected13 at risk EG003
Injection site irritation	General disorders	MedDRA v26.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Localised oedema	General disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0021 events1 affected13 at risk EG003
Oedema	General disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Oedema peripheral	General disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0022 events1 affected13 at risk EG003
Pain	General disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Peripheral swelling	General disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Pyrexia	General disorders	MedDRA v26.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected2 at risk EG0021 events1 affected13 at risk EG003
Swelling	General disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Swelling face	General disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Hypertransaminasaemia	Hepatobiliary disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Jaundice	Hepatobiliary disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Seasonal allergy	Immune system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Bronchitis	Infections and infestations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
COVID-19	Infections and infestations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Conjunctivitis bacterial	Infections and infestations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Escherichia infection	Infections and infestations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Gingivitis	Infections and infestations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Herpes simplex	Infections and infestations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Lymphangitis	Infections and infestations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Oral fungal infection	Infections and infestations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Pneumonia	Infections and infestations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0021 events1 affected13 at risk EG003
Pneumonia aspiration	Infections and infestations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Rash pustular	Infections and infestations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Rhinitis	Infections and infestations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Sputum purulent	Infections and infestations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Tooth abscess	Infections and infestations	MedDRA v26.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Tooth infection	Infections and infestations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Burns first degree	Injury, poisoning and procedural complications	MedDRA v26.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0021 events1 affected13 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Skin abrasion	Injury, poisoning and procedural complications	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA v26.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA v26.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Blood creatinine increased	Investigations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Blood lactate dehydrogenase increased	Investigations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Blood magnesium decreased	Investigations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
International normalised ratio increased	Investigations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Iron binding capacity total decreased	Investigations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Liver function test increased	Investigations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Lymphocyte count decreased	Investigations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Neutrophil count decreased	Investigations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Troponin increased	Investigations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Weight decreased	Investigations	MedDRA v26.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected2 at risk EG0023 events3 affected13 at risk EG003
Weight increased	Investigations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
White blood cell count decreased	Investigations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Abnormal loss of weight	Metabolism and nutrition disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Cachexia	Metabolism and nutrition disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA v26.1	Systematic Assessment	EG0003 events3 affected10 at risk EG0010 events0 affected2 at risk EG0026 events6 affected13 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA v26.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0011 events1 affected2 at risk EG0024 events4 affected13 at risk EG003
Gout	Metabolism and nutrition disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Hypercreatininaemia	Metabolism and nutrition disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA v26.1	Systematic Assessment	EG0003 events2 affected10 at risk EG0010 events0 affected2 at risk EG0021 events1 affected13 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0021 events1 affected13 at risk EG003
Hypermagnesaemia	Metabolism and nutrition disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA v26.1	Systematic Assessment	EG0003 events3 affected10 at risk EG0011 events1 affected2 at risk EG0025 events4 affected13 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA v26.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected2 at risk EG0024 events4 affected13 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA v26.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected2 at risk EG0022 events2 affected13 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Malnutrition	Metabolism and nutrition disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA v26.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected2 at risk EG0022 events2 affected13 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA v26.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0011 events1 affected2 at risk EG0020 events0 affected13 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0021 events1 affected13 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA v26.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0021 events1 affected13 at risk EG003
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Soft tissue necrosis	Musculoskeletal and connective tissue disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Tumour associated fever	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Amnesia	Nervous system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Aphasia	Nervous system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0021 events1 affected13 at risk EG003
Asterixis	Nervous system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Disturbance in attention	Nervous system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Dizziness	Nervous system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0022 events1 affected13 at risk EG003
Dizziness postural	Nervous system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Dysarthria	Nervous system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0021 events1 affected13 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0021 events1 affected13 at risk EG003
Headache	Nervous system disorders	MedDRA v26.1	Systematic Assessment	EG0002 events2 affected10 at risk EG0010 events0 affected2 at risk EG0021 events1 affected13 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Hypogeusia	Nervous system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0021 events1 affected13 at risk EG003
Lethargy	Nervous system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Lumbar radiculopathy	Nervous system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Memory impairment	Nervous system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0021 events1 affected13 at risk EG003
Neuralgia	Nervous system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Neurotoxicity	Nervous system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0021 events1 affected13 at risk EG003
Peripheral motor neuropathy	Nervous system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Peripheral sensorimotor neuropathy	Nervous system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	MedDRA v26.1	Systematic Assessment	EG0003 events1 affected10 at risk EG0010 events0 affected2 at risk EG0023 events3 affected13 at risk EG003
Sciatica	Nervous system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Seizure	Nervous system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Syncope	Nervous system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0021 events1 affected13 at risk EG003
Taste disorder	Nervous system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Tremor	Nervous system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0021 events1 affected13 at risk EG003
Anxiety	Psychiatric disorders	MedDRA v26.1	Systematic Assessment	EG0002 events1 affected10 at risk EG0010 events0 affected2 at risk EG0022 events2 affected13 at risk EG003
Confusional state	Psychiatric disorders	MedDRA v26.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected2 at risk EG0022 events2 affected13 at risk EG003
Delirium	Psychiatric disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Depression	Psychiatric disorders	MedDRA v26.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Hallucination	Psychiatric disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0021 events1 affected13 at risk EG003
Insomnia	Psychiatric disorders	MedDRA v26.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected2 at risk EG0022 events2 affected13 at risk EG003
Poor quality sleep	Psychiatric disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0021 events1 affected13 at risk EG003
Chromaturia	Renal and urinary disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA v26.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Micturition urgency	Renal and urinary disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Genital burning sensation	Reproductive system and breast disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Systematic Assessment	EG0002 events2 affected10 at risk EG0010 events0 affected2 at risk EG0022 events2 affected13 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected2 at risk EG0021 events1 affected13 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Systematic Assessment	EG0003 events3 affected10 at risk EG0010 events0 affected2 at risk EG0024 events4 affected13 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0021 events1 affected13 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0021 events1 affected13 at risk EG003
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0021 events1 affected13 at risk EG003
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0021 events1 affected13 at risk EG003
Laryngeal inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0021 events1 affected13 at risk EG003
Laryngeal ventricle prolapse	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0021 events1 affected13 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA v26.1	Systematic Assessment	EG0003 events3 affected10 at risk EG0010 events0 affected2 at risk EG0025 events5 affected13 at risk EG003
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Erythema multiforme	Skin and subcutaneous tissue disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA v26.1	Systematic Assessment	EG0003 events2 affected10 at risk EG0011 events1 affected2 at risk EG0021 events1 affected13 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0022 events2 affected13 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Rash papular	Skin and subcutaneous tissue disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0021 events1 affected13 at risk EG003
Skin maceration	Skin and subcutaneous tissue disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Skin toxicity	Skin and subcutaneous tissue disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA v26.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Arterial occlusive disease	Vascular disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Flushing	Vascular disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003
Hypertension	Vascular disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected2 at risk EG0021 events1 affected13 at risk EG003
Hypotension	Vascular disorders	MedDRA v26.1	Systematic Assessment	EG0002 events2 affected10 at risk EG0010 events0 affected2 at risk EG0021 events1 affected13 at risk EG003
Raynaud's phenomenon	Vascular disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected13 at risk EG003

ID	Term
D055752	Small Cell Lung Carcinoma
D002289	Carcinoma, Non-Small-Cell Lung
D000077195	Squamous Cell Carcinoma of Head and Neck
D000077277	Esophageal Squamous Cell Carcinoma
D011471	Prostatic Neoplasms
D008545	Melanoma

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002294	Carcinoma, Squamous Cell
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D006258	Head and Neck Neoplasms
D018307	Neoplasms, Squamous Cell
D004938	Esophageal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D004066	Digestive System Diseases
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D011469	Prostatic Diseases
D052801	Male Urogenital Diseases
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009380	Neoplasms, Nerve Tissue
D018326	Nevi and Melanomas
D012878	Skin Neoplasms
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases