Trial Outcomes & Findings for Ramucirumab and Pembrolizumab Versus Standard of Care in Treating Patients With Stage IV or Recurrent Non-small Cell Lung Cancer (A Lung-MAP Non-Match Treatment Trial) (NCT NCT03971474)
NCT ID: NCT03971474
Last Updated: 2024-09-03
Results Overview
Time from date of registration to date of death due to any cause. Participants last known to be alive are censored at date of last contact.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
166 participants
Primary outcome timeframe
From date of registration to a maximum of 2 years and 11 months or death
Results posted on
2024-09-03
Participant Flow
166 participants were initially randomized to the study, 82 to the ramucirumab + pembrolizumab (RP) arm and 84 to the standard of care (SOC) arm. 30 were ineligible, 13 in the RP arm and 17 in the SOC arm. In all, 136 participants were eligible and included in the primary analysis (RP n=69, SOC n=67).
Participant milestones
| Measure |
Standard of Care (Inv. Choice)
Participants receive investigator's choice of standard of care chemotherapy. Allowed regimens include docetaxel (75 mg/m2) IV; ramucirumab (10 mg/kg) plus docetaxel (75 mg/m2) IV once every 21 days; gemcitabine (1,000 mg/m2) IV on days 1 and 8 every 21 days; or for nonsquamous NSCLC patients only, pemetrexed (500 mg/m2) IV once every 21 days. Treatment continues until disease progression as defined in RECIST 1.1, symptomatic deterioration, unacceptable toxicity, treatment delay for any reason \>84 days, or participant choice.
|
Ramucirumab + Pembrolizumab
Participants receive open label ramucirumab (10 mg/kg intravenous \[IV\]) plus pembrolizumab (200 mg IV) once every 21 days. Treatment continues until disease progression as defined in RECIST 1.1, symptomatic deterioration, unacceptable toxicity, treatment delay for any reason \>84 days, or participant choice.
|
|---|---|---|
|
Overall Study
STARTED
|
67
|
69
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
67
|
69
|
Reasons for withdrawal
| Measure |
Standard of Care (Inv. Choice)
Participants receive investigator's choice of standard of care chemotherapy. Allowed regimens include docetaxel (75 mg/m2) IV; ramucirumab (10 mg/kg) plus docetaxel (75 mg/m2) IV once every 21 days; gemcitabine (1,000 mg/m2) IV on days 1 and 8 every 21 days; or for nonsquamous NSCLC patients only, pemetrexed (500 mg/m2) IV once every 21 days. Treatment continues until disease progression as defined in RECIST 1.1, symptomatic deterioration, unacceptable toxicity, treatment delay for any reason \>84 days, or participant choice.
|
Ramucirumab + Pembrolizumab
Participants receive open label ramucirumab (10 mg/kg intravenous \[IV\]) plus pembrolizumab (200 mg IV) once every 21 days. Treatment continues until disease progression as defined in RECIST 1.1, symptomatic deterioration, unacceptable toxicity, treatment delay for any reason \>84 days, or participant choice.
|
|---|---|---|
|
Overall Study
Adverse Event
|
11
|
7
|
|
Overall Study
Refusal unrelated to adverse event
|
5
|
1
|
|
Overall Study
Progression/relapse
|
40
|
47
|
|
Overall Study
Death
|
6
|
3
|
|
Overall Study
Other - not protocol specified
|
5
|
4
|
|
Overall Study
On treatment
|
0
|
7
|
Baseline Characteristics
Percentages are calculated among those with known status only. 10 participants had unknown PD-L1 status.
Baseline characteristics by cohort
| Measure |
Standard of Care (Inv. Choice)
n=67 Participants
Participants receive investigator's choice of standard of care chemotherapy. Allowed regimens include docetaxel (75 mg/m2) IV; ramucirumab (10 mg/kg) plus docetaxel (75 mg/m2) IV once every 21 days; gemcitabine (1,000 mg/m2) IV on days 1 and 8 every 21 days; or for nonsquamous NSCLC patients only, pemetrexed (500 mg/m2) IV once every 21 days. Treatment continues until disease progression as defined in RECIST 1.1, symptomatic deterioration, unacceptable toxicity, treatment delay for any reason \>84 days, or participant choice.
|
Ramucirumab + Pembrolizumab
n=69 Participants
Participants receive open label ramucirumab (10 mg/kg intravenous \[IV\]) plus pembrolizumab (200 mg IV) once every 21 days. Treatment continues until disease progression as defined in RECIST 1.1, symptomatic deterioration, unacceptable toxicity, treatment delay for any reason \>84 days, or participant choice.
|
Total
n=136 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=67 Participants
|
2 Participants
n=69 Participants
|
2 Participants
n=136 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
66 Participants
n=67 Participants
|
66 Participants
n=69 Participants
|
132 Participants
n=136 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=67 Participants
|
1 Participants
n=69 Participants
|
2 Participants
n=136 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=67 Participants
|
1 Participants
n=69 Participants
|
1 Participants
n=136 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=67 Participants
|
1 Participants
n=69 Participants
|
3 Participants
n=136 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=67 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=136 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=67 Participants
|
5 Participants
n=69 Participants
|
11 Participants
n=136 Participants
|
|
Race (NIH/OMB)
White
|
58 Participants
n=67 Participants
|
60 Participants
n=69 Participants
|
118 Participants
n=136 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=67 Participants
|
0 Participants
n=69 Participants
|
1 Participants
n=136 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=67 Participants
|
2 Participants
n=69 Participants
|
2 Participants
n=136 Participants
|
|
Smoking Status
Current Smoker
|
18 Participants
n=67 Participants
|
19 Participants
n=69 Participants
|
37 Participants
n=136 Participants
|
|
Smoking Status
Past Smoker
|
43 Participants
n=67 Participants
|
44 Participants
n=69 Participants
|
87 Participants
n=136 Participants
|
|
Smoking Status
Never Smoked
|
6 Participants
n=67 Participants
|
6 Participants
n=69 Participants
|
12 Participants
n=136 Participants
|
|
Performance Status
0
|
9 Participants
n=67 Participants
|
23 Participants
n=69 Participants
|
32 Participants
n=136 Participants
|
|
Performance Status
1
|
58 Participants
n=67 Participants
|
46 Participants
n=69 Participants
|
104 Participants
n=136 Participants
|
|
Tumor Histology
Adenocarcinoma
|
39 Participants
n=67 Participants
|
36 Participants
n=69 Participants
|
75 Participants
n=136 Participants
|
|
Tumor Histology
Squamous cell
|
27 Participants
n=67 Participants
|
28 Participants
n=69 Participants
|
55 Participants
n=136 Participants
|
|
Tumor Histology
Mixed < 50% squamous cell
|
1 Participants
n=67 Participants
|
0 Participants
n=69 Participants
|
1 Participants
n=136 Participants
|
|
Prior Lines of Treatment for Stage IV Disease
0
|
4 Participants
n=67 Participants
|
4 Participants
n=69 Participants
|
8 Participants
n=136 Participants
|
|
Tumor Histology
Mixed >= 50% squamous cell
|
0 Participants
n=67 Participants
|
1 Participants
n=69 Participants
|
1 Participants
n=136 Participants
|
|
Tumor Histology
Other non-small-cell, NOS
|
0 Participants
n=67 Participants
|
4 Participants
n=69 Participants
|
4 Participants
n=136 Participants
|
|
Prior Lines of Treatment for Stage IV Disease
1
|
33 Participants
n=67 Participants
|
35 Participants
n=69 Participants
|
68 Participants
n=136 Participants
|
|
Prior Lines of Treatment for Stage IV Disease
2
|
17 Participants
n=67 Participants
|
19 Participants
n=69 Participants
|
36 Participants
n=136 Participants
|
|
Prior Lines of Treatment for Stage IV Disease
>= 3
|
13 Participants
n=67 Participants
|
11 Participants
n=69 Participants
|
24 Participants
n=136 Participants
|
|
PD-L1 Status
< 1%
|
26 Participants
n=64 Participants • Percentages are calculated among those with known status only. 10 participants had unknown PD-L1 status.
|
29 Participants
n=62 Participants • Percentages are calculated among those with known status only. 10 participants had unknown PD-L1 status.
|
55 Participants
n=126 Participants • Percentages are calculated among those with known status only. 10 participants had unknown PD-L1 status.
|
|
PD-L1 Status
1% - 49%
|
22 Participants
n=64 Participants • Percentages are calculated among those with known status only. 10 participants had unknown PD-L1 status.
|
21 Participants
n=62 Participants • Percentages are calculated among those with known status only. 10 participants had unknown PD-L1 status.
|
43 Participants
n=126 Participants • Percentages are calculated among those with known status only. 10 participants had unknown PD-L1 status.
|
|
PD-L1 Status
>= 50%
|
16 Participants
n=64 Participants • Percentages are calculated among those with known status only. 10 participants had unknown PD-L1 status.
|
12 Participants
n=62 Participants • Percentages are calculated among those with known status only. 10 participants had unknown PD-L1 status.
|
28 Participants
n=126 Participants • Percentages are calculated among those with known status only. 10 participants had unknown PD-L1 status.
|
|
Age, Continuous
|
65.8 years
n=67 Participants
|
66.4 years
n=69 Participants
|
65.9 years
n=136 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=67 Participants
|
28 Participants
n=69 Participants
|
53 Participants
n=136 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=67 Participants
|
41 Participants
n=69 Participants
|
83 Participants
n=136 Participants
|
PRIMARY outcome
Timeframe: From date of registration to a maximum of 2 years and 11 months or deathPopulation: Eligible and evaluable participants
Time from date of registration to date of death due to any cause. Participants last known to be alive are censored at date of last contact.
Outcome measures
| Measure |
Standard of Care (Inv. Choice)
n=67 Participants
Participants receive investigator's choice of standard of care chemotherapy. Allowed regimens include docetaxel (75 mg/m2) IV; ramucirumab (10 mg/kg) plus docetaxel (75 mg/m2) IV once every 21 days; gemcitabine (1,000 mg/m2) IV on days 1 and 8 every 21 days; or for nonsquamous NSCLC patients only, pemetrexed (500 mg/m2) IV once every 21 days. Treatment continues until disease progression as defined in RECIST 1.1, symptomatic deterioration, unacceptable toxicity, treatment delay for any reason \>84 days, or participant choice.
|
Ramucirumab + Pembrolizumab
n=69 Participants
Participants receive open label ramucirumab (10 mg/kg intravenous \[IV\]) plus pembrolizumab (200 mg IV) once every 21 days. Treatment continues until disease progression as defined in RECIST 1.1, symptomatic deterioration, unacceptable toxicity, treatment delay for any reason \>84 days, or participant choice.
|
|---|---|---|
|
Overall Survival (OS)
|
11.6 months
Interval 9.9 to 13.0
|
14.5 months
Interval 13.9 to 16.1
|
SECONDARY outcome
Timeframe: From date of registration to a maximum of 3 years or deathPopulation: Eligible and evaluable participants
Percentage of participants with a complete or partial, confirmed or unconfirmed response. Complete Response (CR): Complete disappearance of all target and non-target lesions. No new lesions. No disease related symptoms. Any lymph nodes (whether target or non-target) must have reduction in short axis to \< 1.0 cm. All disease must be assessed using the same technique as baseline. Partial Response (PR): Applies only to participants with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of appropriate diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. All target measurable lesions must be assessed using the same techniques as baseline.
Outcome measures
| Measure |
Standard of Care (Inv. Choice)
n=67 Participants
Participants receive investigator's choice of standard of care chemotherapy. Allowed regimens include docetaxel (75 mg/m2) IV; ramucirumab (10 mg/kg) plus docetaxel (75 mg/m2) IV once every 21 days; gemcitabine (1,000 mg/m2) IV on days 1 and 8 every 21 days; or for nonsquamous NSCLC patients only, pemetrexed (500 mg/m2) IV once every 21 days. Treatment continues until disease progression as defined in RECIST 1.1, symptomatic deterioration, unacceptable toxicity, treatment delay for any reason \>84 days, or participant choice.
|
Ramucirumab + Pembrolizumab
n=69 Participants
Participants receive open label ramucirumab (10 mg/kg intravenous \[IV\]) plus pembrolizumab (200 mg IV) once every 21 days. Treatment continues until disease progression as defined in RECIST 1.1, symptomatic deterioration, unacceptable toxicity, treatment delay for any reason \>84 days, or participant choice.
|
|---|---|---|
|
Response Rate (RR)
|
28 Percentage of participants
Interval 19.0 to 37.0
|
22 Percentage of participants
Interval 14.0 to 30.0
|
SECONDARY outcome
Timeframe: From date of registration to a maximum of 3 years or deathPopulation: Eligible and evaluable participants
Percentage of participants with complete response (CR), partial response (PR), or stable disease as best response. CR: Complete disappearance of all target and non-target lesions. No new lesions. No disease related symptoms. Any lymph nodes must have reduction in short axis to \<1.0cm. All disease must be assessed using the same technique as baseline. PR: Applies only to participants with at least one measurable lesion. At least 30% decrease under baseline of the sum of appropriate diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. All target measurable lesions must be assessed using the same techniques as baseline. Stable disease: Does not qualify for CR, PR, Progression or Symptomatic Deterioration. All target measurable lesions must be assessed using the same techniques as baseline.
Outcome measures
| Measure |
Standard of Care (Inv. Choice)
n=67 Participants
Participants receive investigator's choice of standard of care chemotherapy. Allowed regimens include docetaxel (75 mg/m2) IV; ramucirumab (10 mg/kg) plus docetaxel (75 mg/m2) IV once every 21 days; gemcitabine (1,000 mg/m2) IV on days 1 and 8 every 21 days; or for nonsquamous NSCLC patients only, pemetrexed (500 mg/m2) IV once every 21 days. Treatment continues until disease progression as defined in RECIST 1.1, symptomatic deterioration, unacceptable toxicity, treatment delay for any reason \>84 days, or participant choice.
|
Ramucirumab + Pembrolizumab
n=69 Participants
Participants receive open label ramucirumab (10 mg/kg intravenous \[IV\]) plus pembrolizumab (200 mg IV) once every 21 days. Treatment continues until disease progression as defined in RECIST 1.1, symptomatic deterioration, unacceptable toxicity, treatment delay for any reason \>84 days, or participant choice.
|
|---|---|---|
|
Disease Control Rate (DCR)
|
73 Percentage of participants
Interval 64.0 to 82.0
|
75 Percentage of participants
Interval 67.0 to 84.0
|
SECONDARY outcome
Timeframe: From date of registration to a maximum of 3 years or deathPopulation: Eligible and evaluable participants who had a response
Time from date of first documentation of response (complete or partial) to date of first documentation of progression assessed by local review or symptomatic deterioration, or death due to any cause among participants who achieve a response. Participants last known to be alive without report of progression are censored at date of last disease assessment. For participants with a missing scan (or consecutive missing scans) whose subsequent scan determines progression, the expected date of the first missing scan (as defined by the disease assessment schedule) is used as the date of progression.
Outcome measures
| Measure |
Standard of Care (Inv. Choice)
n=19 Participants
Participants receive investigator's choice of standard of care chemotherapy. Allowed regimens include docetaxel (75 mg/m2) IV; ramucirumab (10 mg/kg) plus docetaxel (75 mg/m2) IV once every 21 days; gemcitabine (1,000 mg/m2) IV on days 1 and 8 every 21 days; or for nonsquamous NSCLC patients only, pemetrexed (500 mg/m2) IV once every 21 days. Treatment continues until disease progression as defined in RECIST 1.1, symptomatic deterioration, unacceptable toxicity, treatment delay for any reason \>84 days, or participant choice.
|
Ramucirumab + Pembrolizumab
n=15 Participants
Participants receive open label ramucirumab (10 mg/kg intravenous \[IV\]) plus pembrolizumab (200 mg IV) once every 21 days. Treatment continues until disease progression as defined in RECIST 1.1, symptomatic deterioration, unacceptable toxicity, treatment delay for any reason \>84 days, or participant choice.
|
|---|---|---|
|
Duration of Response (DOR)
|
5.6 months
Interval 4.6 to 7.8
|
12.9 months
Interval 2.8 to
Insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Duration of treatment and follow-up until death or 3 years post randomizationPopulation: Participants who were eligible and received at least one dose of protocol treatment
Only adverse events that are possibly, probably or definitely related to study drugs are reported. CTCAE Version 5.0 was used for all AE reporting.
Outcome measures
| Measure |
Standard of Care (Inv. Choice)
n=60 Participants
Participants receive investigator's choice of standard of care chemotherapy. Allowed regimens include docetaxel (75 mg/m2) IV; ramucirumab (10 mg/kg) plus docetaxel (75 mg/m2) IV once every 21 days; gemcitabine (1,000 mg/m2) IV on days 1 and 8 every 21 days; or for nonsquamous NSCLC patients only, pemetrexed (500 mg/m2) IV once every 21 days. Treatment continues until disease progression as defined in RECIST 1.1, symptomatic deterioration, unacceptable toxicity, treatment delay for any reason \>84 days, or participant choice.
|
Ramucirumab + Pembrolizumab
n=69 Participants
Participants receive open label ramucirumab (10 mg/kg intravenous \[IV\]) plus pembrolizumab (200 mg IV) once every 21 days. Treatment continues until disease progression as defined in RECIST 1.1, symptomatic deterioration, unacceptable toxicity, treatment delay for any reason \>84 days, or participant choice.
|
|---|---|---|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pneumonitis
|
1 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Respiratory failure
|
2 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Abdominal infection
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Acidosis
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Acute kidney injury
|
1 Participants
|
4 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Adrenal insufficiency
|
0 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Alanine aminotransferase increased
|
2 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Anemia
|
4 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Anorexia
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Arterial thromboembolism
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Arthralgia
|
0 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Ascites
|
1 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Aspartate aminotransferase increased
|
2 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Blood bilirubin increased
|
0 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Bronchopulmonary hemorrhage
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Cardiac arrest
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Colitis
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Colonic perforation
|
2 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Cough
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Creatinine increased
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Death NOS
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Dehydration
|
3 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Delirium
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Diarrhea
|
2 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Dizziness
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Duodenal ulcer
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Dyspnea
|
3 Participants
|
3 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Encephalopathy
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Fatigue
|
4 Participants
|
4 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Febrile neutropenia
|
3 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Gastric hemorrhage
|
1 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Gastrointestinal disorders - Other, specify
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Generalized muscle weakness
|
0 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypertension
|
2 Participants
|
9 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypoalbuminemia
|
2 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypokalemia
|
1 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypomagnesemia
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hyponatremia
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypophosphatemia
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypotension
|
3 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypoxia
|
2 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Infusion related reaction
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Lung infection
|
4 Participants
|
4 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Lymphocyte count decreased
|
11 Participants
|
3 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Mucositis oral
|
4 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Multi-organ failure
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Muscle weakness lower limb
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Nausea
|
3 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Neutrophil count decreased
|
20 Participants
|
3 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pericardial effusion
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Peripheral sensory neuropathy
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Platelet count decreased
|
3 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pleural effusion
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pneumothorax
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Portal hypertension
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Proteinuria
|
0 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Sepsis
|
5 Participants
|
3 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Sinus tachycardia
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Stroke
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Syncope
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Thromboembolic event
|
2 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Vomiting
|
2 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Weight loss
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Wheezing
|
0 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
White blood cell decreased
|
17 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From date of registration to a maximum of 3 years or deathPopulation: Eligible and evaluable participants
Time from date of registration to date of first documentation of progression assessed by local review or symptomatic deterioration, or death due to any cause. Participants last known to be alive without report of progression are censored at date of last disease assessment. For participants with a missing scan (or consecutive missing scans) whose subsequent scan determines progression, the expected date of the first missing scan is used as the date of progression. Symptomatic deterioration: Global deterioration of health status requiring discontinuation of treatment without objective evidence of progression. Efforts should be made to obtain objective evidence of progression after discontinuation.
Outcome measures
| Measure |
Standard of Care (Inv. Choice)
n=67 Participants
Participants receive investigator's choice of standard of care chemotherapy. Allowed regimens include docetaxel (75 mg/m2) IV; ramucirumab (10 mg/kg) plus docetaxel (75 mg/m2) IV once every 21 days; gemcitabine (1,000 mg/m2) IV on days 1 and 8 every 21 days; or for nonsquamous NSCLC patients only, pemetrexed (500 mg/m2) IV once every 21 days. Treatment continues until disease progression as defined in RECIST 1.1, symptomatic deterioration, unacceptable toxicity, treatment delay for any reason \>84 days, or participant choice.
|
Ramucirumab + Pembrolizumab
n=69 Participants
Participants receive open label ramucirumab (10 mg/kg intravenous \[IV\]) plus pembrolizumab (200 mg IV) once every 21 days. Treatment continues until disease progression as defined in RECIST 1.1, symptomatic deterioration, unacceptable toxicity, treatment delay for any reason \>84 days, or participant choice.
|
|---|---|---|
|
Investigator Assessed-progression-free Survival (IA-PFS)
|
5.2 months
Interval 4.2 to 5.7
|
4.5 months
Interval 4.2 to 6.1
|
SECONDARY outcome
Timeframe: From date of registration to a maximum of 3 years or deathPopulation: Eligible and evaluable participants
Number of participants who died due to any cause. Participants last known to be alive are censored at date of last contact.
Outcome measures
| Measure |
Standard of Care (Inv. Choice)
n=67 Participants
Participants receive investigator's choice of standard of care chemotherapy. Allowed regimens include docetaxel (75 mg/m2) IV; ramucirumab (10 mg/kg) plus docetaxel (75 mg/m2) IV once every 21 days; gemcitabine (1,000 mg/m2) IV on days 1 and 8 every 21 days; or for nonsquamous NSCLC patients only, pemetrexed (500 mg/m2) IV once every 21 days. Treatment continues until disease progression as defined in RECIST 1.1, symptomatic deterioration, unacceptable toxicity, treatment delay for any reason \>84 days, or participant choice.
|
Ramucirumab + Pembrolizumab
n=69 Participants
Participants receive open label ramucirumab (10 mg/kg intravenous \[IV\]) plus pembrolizumab (200 mg IV) once every 21 days. Treatment continues until disease progression as defined in RECIST 1.1, symptomatic deterioration, unacceptable toxicity, treatment delay for any reason \>84 days, or participant choice.
|
|---|---|---|
|
Overall Survival (OS), Subgroup Analysis by Stratification Factors
PD-L1: < 1%
|
21 Participants
|
21 Participants
|
|
Overall Survival (OS), Subgroup Analysis by Stratification Factors
PD-L1: >= 1%
|
27 Participants
|
19 Participants
|
|
Overall Survival (OS), Subgroup Analysis by Stratification Factors
Histology: Squamous
|
24 Participants
|
18 Participants
|
|
Overall Survival (OS), Subgroup Analysis by Stratification Factors
Histology: Non-squamous
|
27 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: From date of registration to a maximum of 3 years or deathPopulation: Eligible and evaluable participants
Number of participants with progression assessed by local review or symptomatic deterioration, or death due to any cause. Participants last known to be alive without report of progression are censored at date of last disease assessment. For participants with a missing scan (or consecutive missing scans) whose subsequent scan determines progression, the expected date of the first missing scan is used as the date of progression. Symptomatic deterioration: Global deterioration of health status requiring discontinuation of treatment without objective evidence of progression. Efforts should be made to obtain objective evidence of progression after discontinuation.
Outcome measures
| Measure |
Standard of Care (Inv. Choice)
n=67 Participants
Participants receive investigator's choice of standard of care chemotherapy. Allowed regimens include docetaxel (75 mg/m2) IV; ramucirumab (10 mg/kg) plus docetaxel (75 mg/m2) IV once every 21 days; gemcitabine (1,000 mg/m2) IV on days 1 and 8 every 21 days; or for nonsquamous NSCLC patients only, pemetrexed (500 mg/m2) IV once every 21 days. Treatment continues until disease progression as defined in RECIST 1.1, symptomatic deterioration, unacceptable toxicity, treatment delay for any reason \>84 days, or participant choice.
|
Ramucirumab + Pembrolizumab
n=69 Participants
Participants receive open label ramucirumab (10 mg/kg intravenous \[IV\]) plus pembrolizumab (200 mg IV) once every 21 days. Treatment continues until disease progression as defined in RECIST 1.1, symptomatic deterioration, unacceptable toxicity, treatment delay for any reason \>84 days, or participant choice.
|
|---|---|---|
|
Investigator-Assessed Progression-Free Survival (IA-PFS), Subgroup Analysis by Stratification Factors
Histology: Non-squamous
|
34 Participants
|
34 Participants
|
|
Investigator-Assessed Progression-Free Survival (IA-PFS), Subgroup Analysis by Stratification Factors
Histology: Squamous
|
28 Participants
|
23 Participants
|
|
Investigator-Assessed Progression-Free Survival (IA-PFS), Subgroup Analysis by Stratification Factors
PD-L1: < 1%
|
25 Participants
|
27 Participants
|
|
Investigator-Assessed Progression-Free Survival (IA-PFS), Subgroup Analysis by Stratification Factors
PD-L1: >= 1%
|
34 Participants
|
24 Participants
|
Adverse Events
Standard of Care (Inv. Choice)
Serious events: 11 serious events
Other events: 60 other events
Deaths: 51 deaths
Ramucirumab + Pembrolizumab
Serious events: 28 serious events
Other events: 69 other events
Deaths: 45 deaths
Serious adverse events
| Measure |
Standard of Care (Inv. Choice)
n=60 participants at risk
Participants receive investigator's choice of standard of care chemotherapy. Allowed regimens include docetaxel (75 mg/m2) IV; ramucirumab (10 mg/kg) plus docetaxel (75 mg/m2) IV once every 21 days; gemcitabine (1,000 mg/m2) IV on days 1 and 8 every 21 days; or for nonsquamous NSCLC patients only, pemetrexed (500 mg/m2) IV once every 21 days. Treatment continues until disease progression as defined in RECIST 1.1, symptomatic deterioration, unacceptable toxicity, treatment delay for any reason \>84 days, or participant choice.
|
Ramucirumab + Pembrolizumab
n=69 participants at risk
Participants receive open label ramucirumab (10 mg/kg intravenous \[IV\]) plus pembrolizumab (200 mg IV) once every 21 days. Treatment continues until disease progression as defined in RECIST 1.1, symptomatic deterioration, unacceptable toxicity, treatment delay for any reason \>84 days, or participant choice.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
1.7%
1/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
0.00%
0/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
1.4%
1/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
1.4%
1/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
1.4%
1/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
1.4%
1/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
1.4%
1/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Cardiac disorders
Pericardial effusion
|
1.7%
1/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
2.9%
2/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
1.4%
1/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
2.9%
2/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
1.4%
1/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Gastrointestinal disorders
Colonic perforation
|
3.3%
2/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
0.00%
0/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
1.4%
1/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
0.00%
0/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
1.4%
1/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Gastrointestinal disorders
Gastrointestinal disorders-Other
|
1.7%
1/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
0.00%
0/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
2.9%
2/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
General disorders
Death NOS
|
0.00%
0/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
1.4%
1/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
General disorders
Disease progression
|
0.00%
0/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
1.4%
1/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
General disorders
Fatigue
|
0.00%
0/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
2.9%
2/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
General disorders
Fever
|
0.00%
0/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
2.9%
2/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
General disorders
Infusion site extravasation
|
1.7%
1/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
0.00%
0/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Infections and infestations
Infections and infestations-Other
|
1.7%
1/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
0.00%
0/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Infections and infestations
Lung infection
|
5.0%
3/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
10.1%
7/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Infections and infestations
Sepsis
|
5.0%
3/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
7.2%
5/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
1.4%
1/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
2.9%
2/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
1.4%
1/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
1.4%
1/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
1.4%
1/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
1.4%
1/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
2.9%
2/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Investigations
Cardiac troponin I increased
|
0.00%
0/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
1.4%
1/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Investigations
Cardiac troponin T increased
|
0.00%
0/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
1.4%
1/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Investigations
Creatinine increased
|
0.00%
0/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
1.4%
1/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
2.9%
2/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Investigations
Neutrophil count decreased
|
1.7%
1/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
1.4%
1/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Investigations
Weight loss
|
0.00%
0/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
1.4%
1/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
2.9%
2/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
1.4%
1/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
1.4%
1/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
1.4%
1/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
1.4%
1/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
1.4%
1/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
1.4%
1/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
1.7%
1/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
0.00%
0/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
4.3%
3/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl
|
3.3%
2/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
1.4%
1/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
2.9%
2/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
1.4%
1/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Nervous system disorders
Seizure
|
0.00%
0/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
1.4%
1/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
1.4%
1/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Nervous system disorders
Tremor
|
0.00%
0/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
1.4%
1/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Psychiatric disorders
Confusion
|
1.7%
1/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
0.00%
0/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
1.4%
1/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
5.8%
4/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
2.9%
2/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
0.00%
0/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
1.4%
1/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
1.4%
1/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.3%
2/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
10.1%
7/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
1.4%
1/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
8.7%
6/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
1.4%
1/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.7%
1/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
1.4%
1/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
1.4%
1/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
6.7%
4/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
7.2%
5/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders-Ot
|
0.00%
0/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
2.9%
2/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
2.9%
2/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders-Other
|
0.00%
0/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
1.4%
1/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Vascular disorders
Arterial thromboembolism
|
0.00%
0/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
1.4%
1/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
7.2%
5/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Vascular disorders
Hypotension
|
0.00%
0/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
2.9%
2/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Vascular disorders
Thromboembolic event
|
1.7%
1/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
4.3%
3/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
Other adverse events
| Measure |
Standard of Care (Inv. Choice)
n=60 participants at risk
Participants receive investigator's choice of standard of care chemotherapy. Allowed regimens include docetaxel (75 mg/m2) IV; ramucirumab (10 mg/kg) plus docetaxel (75 mg/m2) IV once every 21 days; gemcitabine (1,000 mg/m2) IV on days 1 and 8 every 21 days; or for nonsquamous NSCLC patients only, pemetrexed (500 mg/m2) IV once every 21 days. Treatment continues until disease progression as defined in RECIST 1.1, symptomatic deterioration, unacceptable toxicity, treatment delay for any reason \>84 days, or participant choice.
|
Ramucirumab + Pembrolizumab
n=69 participants at risk
Participants receive open label ramucirumab (10 mg/kg intravenous \[IV\]) plus pembrolizumab (200 mg IV) once every 21 days. Treatment continues until disease progression as defined in RECIST 1.1, symptomatic deterioration, unacceptable toxicity, treatment delay for any reason \>84 days, or participant choice.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
40/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
33.3%
23/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
8.3%
5/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
0.00%
0/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
15.0%
9/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
7.2%
5/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Endocrine disorders
Hypothyroidism
|
1.7%
1/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
26.1%
18/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Eye disorders
Dry eye
|
6.7%
4/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
1.4%
1/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Eye disorders
Watering eyes
|
26.7%
16/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
2.9%
2/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
15/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
11.6%
8/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Gastrointestinal disorders
Ascites
|
5.0%
3/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
2.9%
2/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Gastrointestinal disorders
Colonic perforation
|
5.0%
3/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
0.00%
0/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Gastrointestinal disorders
Constipation
|
20.0%
12/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
17.4%
12/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
48.3%
29/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
27.5%
19/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
1.7%
1/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
8.7%
6/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
11.7%
7/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
2.9%
2/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
6.7%
4/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
2.9%
2/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Gastrointestinal disorders
Mucositis oral
|
31.7%
19/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
4.3%
3/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Gastrointestinal disorders
Nausea
|
40.0%
24/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
33.3%
23/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Gastrointestinal disorders
Oral pain
|
6.7%
4/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
1.4%
1/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Gastrointestinal disorders
Vomiting
|
23.3%
14/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
18.8%
13/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
General disorders
Chills
|
13.3%
8/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
7.2%
5/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
General disorders
Edema limbs
|
23.3%
14/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
13.0%
9/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
General disorders
Fatigue
|
70.0%
42/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
56.5%
39/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
General disorders
Fever
|
16.7%
10/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
8.7%
6/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
General disorders
Flu like symptoms
|
5.0%
3/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
2.9%
2/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
General disorders
Non-cardiac chest pain
|
8.3%
5/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
2.9%
2/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
General disorders
Pain
|
13.3%
8/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
14.5%
10/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Infections and infestations
Infections and infestations-Other
|
5.0%
3/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
11.6%
8/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Infections and infestations
Lung infection
|
16.7%
10/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
7.2%
5/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Infections and infestations
Sepsis
|
8.3%
5/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
0.00%
0/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Infections and infestations
Sinusitis
|
6.7%
4/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
1.4%
1/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Infections and infestations
Skin infection
|
5.0%
3/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
7.2%
5/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Infections and infestations
Thrush
|
8.3%
5/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
0.00%
0/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Infections and infestations
Upper respiratory infection
|
6.7%
4/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
2.9%
2/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Infections and infestations
Urinary tract infection
|
5.0%
3/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
5.8%
4/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Injury, poisoning and procedural complications
Bruising
|
8.3%
5/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
2.9%
2/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
10.0%
6/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
4.3%
3/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
5.0%
3/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
1.4%
1/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Investigations
Alanine aminotransferase increased
|
15.0%
9/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
8.7%
6/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
18.3%
11/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
13.0%
9/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Investigations
Alkaline phosphatase increased
|
21.7%
13/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
20.3%
14/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Investigations
Blood bilirubin increased
|
8.3%
5/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
5.8%
4/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Investigations
Creatinine increased
|
18.3%
11/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
15.9%
11/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Investigations
Investigations-Other
|
16.7%
10/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
7.2%
5/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Investigations
Lymphocyte count decreased
|
40.0%
24/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
18.8%
13/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Investigations
Neutrophil count decreased
|
43.3%
26/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
8.7%
6/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Investigations
Platelet count decreased
|
28.3%
17/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
27.5%
19/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Investigations
Thyroid stimulating hormone increased
|
3.3%
2/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
14.5%
10/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Investigations
Weight loss
|
25.0%
15/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
24.6%
17/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Investigations
White blood cell decreased
|
45.0%
27/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
15.9%
11/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
36.7%
22/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
34.8%
24/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
11.7%
7/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
11.6%
8/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
6.7%
4/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
1.4%
1/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
15.0%
9/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
18.8%
13/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
18.3%
11/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
8.7%
6/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
3.3%
2/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
5.8%
4/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
45.0%
27/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
44.9%
31/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
18.3%
11/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
13.0%
9/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
5.0%
3/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
4.3%
3/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
18.3%
11/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
11.6%
8/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
11.7%
7/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
2.9%
2/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
28.3%
17/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
39.1%
27/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
6.7%
4/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
2.9%
2/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.0%
3/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
8.7%
6/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
5/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
14.5%
10/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
18.3%
11/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
1.4%
1/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
5.0%
3/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
4.3%
3/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
13.3%
8/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
14.5%
10/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.7%
4/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
10.1%
7/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
15.0%
9/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
10.1%
7/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Nervous system disorders
Dizziness
|
25.0%
15/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
18.8%
13/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Nervous system disorders
Dysgeusia
|
21.7%
13/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
10.1%
7/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Nervous system disorders
Headache
|
25.0%
15/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
23.2%
16/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Nervous system disorders
Lethargy
|
3.3%
2/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
5.8%
4/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Nervous system disorders
Paresthesia
|
8.3%
5/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
2.9%
2/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
5.0%
3/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
1.4%
1/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
16.7%
10/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
7.2%
5/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Psychiatric disorders
Anxiety
|
10.0%
6/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
2.9%
2/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Psychiatric disorders
Confusion
|
5.0%
3/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
2.9%
2/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Psychiatric disorders
Depression
|
5.0%
3/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
4.3%
3/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Psychiatric disorders
Insomnia
|
16.7%
10/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
7.2%
5/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Renal and urinary disorders
Hematuria
|
5.0%
3/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
10.1%
7/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Renal and urinary disorders
Proteinuria
|
23.3%
14/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
39.1%
27/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
6.7%
4/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
5.8%
4/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
28.3%
17/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
26.1%
18/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
43.3%
26/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
37.7%
26/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
33.3%
20/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
11.6%
8/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
1.7%
1/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
7.2%
5/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
11.7%
7/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
2.9%
2/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.7%
4/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
4.3%
3/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
11.7%
7/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
5.8%
4/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
7.2%
5/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
5.0%
3/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
0.00%
0/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
15.0%
9/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
11.6%
8/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders-Ot
|
3.3%
2/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
5.8%
4/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
10.0%
6/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
2.9%
2/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
5.0%
3/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
5.8%
4/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.0%
3/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
11.6%
8/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
21.7%
13/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
2.9%
2/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.3%
5/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
8.7%
6/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
10.0%
6/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
0.00%
0/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
8.3%
5/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
0.00%
0/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.7%
4/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
10.1%
7/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
1.7%
1/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
5.8%
4/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
8.3%
5/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
10.1%
7/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders-Other
|
15.0%
9/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
4.3%
3/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Vascular disorders
Hypertension
|
25.0%
15/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
33.3%
23/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Vascular disorders
Hypotension
|
13.3%
8/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
11.6%
8/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
|
Vascular disorders
Thromboembolic event
|
5.0%
3/60 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
0.00%
0/69 • Duration of treatment and follow-up until death or 3 years post randomization, whichever occurs first.
CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 129 participants were treated and evaluated for AEs: 69 on the Ramucirumab + Pembrolizumab arm and 60 on the Standard of Care arm. All-cause mortality is reported for all eligible participants (69 on the Ramucirumab + Pembrolizumab arm and 67 on the Standard of Care arm), including those who did not receive protocol treatment.
|
Additional Information
Lung Committee Statistician
SWOG Statistics and Data Management Center
Phone: 2066674623
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60