Trial Outcomes & Findings for Ramucirumab + Pembrolizumab in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (NCT NCT03650764)
NCT ID: NCT03650764
Last Updated: 2026-08-17
Results Overview
-The RP2D of ramucirumab is defined as the highest dose level at which fewer than 2 participants of a cohort of three participants experience a dose-limiting toxicity (DLT) during the first cycle.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
43 participants
Primary outcome timeframe
Completion of first cycle of treatment (each cycle is 21 days) for all participants enrolled in Phase I portion of study (estimated to be 2.5 months)
Results posted on
2026-08-17
Participant Flow
Participant milestones
| Measure |
Phase I Dose Level 1 : Ramucirumab (10 mg/kg) + Pembrolizumab
Participants enrolled in Phase I Dose Level 1 received 10 mg/kg ramucirumab administered intravenously (IV) on Day 1. Pembrolizumab was administered as per standard of care (SOC) IV at a dose of 200 mg on Day 1. Each cycle was 21 days.
|
Phase II: Ramucirumab (10 mg/kg) + Pembrolizumab
Participants enrolled in the Phase II portion received 10 mg/kg intravenous ramucirumab which was the recommended phase 2 dose (RP2D) determined during the Phase I portion on Day 1. Pembrolizumab was administered as per standard of care (SOC) IV at a dose of 200 mg on Day 1. Each cycle was 21 days.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
40
|
|
Overall Study
COMPLETED
|
3
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
7
|
Reasons for withdrawal
| Measure |
Phase I Dose Level 1 : Ramucirumab (10 mg/kg) + Pembrolizumab
Participants enrolled in Phase I Dose Level 1 received 10 mg/kg ramucirumab administered intravenously (IV) on Day 1. Pembrolizumab was administered as per standard of care (SOC) IV at a dose of 200 mg on Day 1. Each cycle was 21 days.
|
Phase II: Ramucirumab (10 mg/kg) + Pembrolizumab
Participants enrolled in the Phase II portion received 10 mg/kg intravenous ramucirumab which was the recommended phase 2 dose (RP2D) determined during the Phase I portion on Day 1. Pembrolizumab was administered as per standard of care (SOC) IV at a dose of 200 mg on Day 1. Each cycle was 21 days.
|
|---|---|---|
|
Overall Study
Death
|
0
|
2
|
|
Overall Study
Did not start treatment - infection
|
0
|
1
|
|
Overall Study
Did not start treatment - withdrawal by subject
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Ramucirumab + Pembrolizumab in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Baseline characteristics by cohort
| Measure |
Phase I Dose Level 1 : Ramucirumab (10 mg/kg) + Pembrolizumab
n=3 Participants
Participants enrolled in Phase I Dose Level 1 received 10 mg/kg ramucirumab administered intravenously (IV) on Day 1. Pembrolizumab was administered as per standard of care (SOC) IV at a dose of 200 mg on Day 1. Each cycle was 21 days.
|
Phase II: Ramucirumab (10 mg/kg) + Pembrolizumab
n=40 Participants
Participants enrolled in the Phase II portion received 10 mg/kg intravenous ramucirumab which was the recommended phase 2 dose (RP2D) determined during the Phase I portion on Day 1. Pembrolizumab was administered as per standard of care (SOC) IV at a dose of 200 mg on Day 1. Each cycle was 21 days.
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 years
n=51 Participants
|
64 years
n=51 Participants
|
64 years
n=102 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=51 Participants
|
4 Participants
n=51 Participants
|
4 Participants
n=102 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=51 Participants
|
36 Participants
n=51 Participants
|
39 Participants
n=102 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=102 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=51 Participants
|
40 Participants
n=51 Participants
|
43 Participants
n=102 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=102 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=102 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=51 Participants
|
1 Participants
n=51 Participants
|
1 Participants
n=102 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=102 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=51 Participants
|
4 Participants
n=51 Participants
|
4 Participants
n=102 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=51 Participants
|
35 Participants
n=51 Participants
|
38 Participants
n=102 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=102 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=102 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=51 Participants
|
40 participants
n=51 Participants
|
43 participants
n=102 Participants
|
PRIMARY outcome
Timeframe: Completion of first cycle of treatment (each cycle is 21 days) for all participants enrolled in Phase I portion of study (estimated to be 2.5 months)-The RP2D of ramucirumab is defined as the highest dose level at which fewer than 2 participants of a cohort of three participants experience a dose-limiting toxicity (DLT) during the first cycle.
Outcome measures
| Measure |
Phase I Dose Level 1 : Ramucirumab (10 mg/kg) + Pembrolizumab
n=3 Participants
Participants enrolled in Phase I Dose Level 1 received 10 mg/kg ramucirumab administered intravenously (IV) on Day 1. Pembrolizumab was administered as per standard of care (SOC) IV at a dose of 200 mg on Day 1. Each cycle was 21 days.
|
Phase II: Ramucirumab (10 mg/kg) + Pembrolizumab
Participants enrolled in the Phase II portion received 10 mg/kg intravenous ramucirumab which was the recommended phase 2 dose (RP2D) determined during the Phase I portion on Day 1. Pembrolizumab was administered as per standard of care (SOC) IV at a dose of 200 mg on Day 1. Each cycle was 21 days.
|
|---|---|---|
|
Recommended Phase 2 Dose (RP2D) of Ramucirumab Combined With Fixed Dose Pembrolizumab (Phase I Participants Only)
|
10 mg/kg
|
—
|
PRIMARY outcome
Timeframe: Through completion of treatment (median length of follow-up 162 days, full range 1-2240 days)Population: 7 participants in Phase II were not evaluable for this outcome measure.
* Objective response rate = number of participants with complete response + partial response as measured per RECIST 1.1 * Complete response (CR)=Disappearance of all target lesions and non-target lesions along with normalizations of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. * Partial response (PR)=At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Phase I Dose Level 1 : Ramucirumab (10 mg/kg) + Pembrolizumab
n=33 Participants
Participants enrolled in Phase I Dose Level 1 received 10 mg/kg ramucirumab administered intravenously (IV) on Day 1. Pembrolizumab was administered as per standard of care (SOC) IV at a dose of 200 mg on Day 1. Each cycle was 21 days.
|
Phase II: Ramucirumab (10 mg/kg) + Pembrolizumab
Participants enrolled in the Phase II portion received 10 mg/kg intravenous ramucirumab which was the recommended phase 2 dose (RP2D) determined during the Phase I portion on Day 1. Pembrolizumab was administered as per standard of care (SOC) IV at a dose of 200 mg on Day 1. Each cycle was 21 days.
|
|---|---|---|
|
Objective Response Rate of Ramucirumab and Pembrolizumab (Phase II Participants Only)
|
18 Participants
|
—
|
SECONDARY outcome
Timeframe: Through 28 days after completion of treatment (median length of follow-up 183 days, full range 14-2240 days)Population: 3 participants in Phase II were not evaluable for this outcome measure
-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.
Outcome measures
| Measure |
Phase I Dose Level 1 : Ramucirumab (10 mg/kg) + Pembrolizumab
n=3 Participants
Participants enrolled in Phase I Dose Level 1 received 10 mg/kg ramucirumab administered intravenously (IV) on Day 1. Pembrolizumab was administered as per standard of care (SOC) IV at a dose of 200 mg on Day 1. Each cycle was 21 days.
|
Phase II: Ramucirumab (10 mg/kg) + Pembrolizumab
n=37 Participants
Participants enrolled in the Phase II portion received 10 mg/kg intravenous ramucirumab which was the recommended phase 2 dose (RP2D) determined during the Phase I portion on Day 1. Pembrolizumab was administered as per standard of care (SOC) IV at a dose of 200 mg on Day 1. Each cycle was 21 days.
|
|---|---|---|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Dysphagia
|
1 Participants
|
14 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Epiglottitis
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Dyspnea
|
3 Participants
|
16 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Nasal congestion
|
1 Participants
|
7 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Pharyngeal hemorrhage
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Postnasal drip
|
1 Participants
|
4 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Productive cough
|
0 Participants
|
7 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Respiratory failure
|
1 Participants
|
3 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Sleep apnea
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Sleep apnea
|
1 Participants
|
0 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Sore throat
|
1 Participants
|
9 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Wheezing
|
0 Participants
|
2 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Subcutaneous nodules
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Erythema multiforme
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Hemangiomas
|
1 Participants
|
0 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Palmar-plantar erythrodysesthesia syndrome
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Pruritus
|
1 Participants
|
7 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Skin induration
|
0 Participants
|
6 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Hypertension
|
1 Participants
|
9 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Hypotension
|
1 Participants
|
11 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Lymphedema
|
1 Participants
|
5 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Thromboembolic event
|
0 Participants
|
2 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Anemia
|
1 Participants
|
3 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Hemolytic uremic syndrome
|
1 Participants
|
0 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Anemia
|
1 Participants
|
33 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Leukocytosis
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Myocardial infarction
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Pericardial effusion
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Sinus bradycardia
|
0 Participants
|
5 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Sinus tachycardia
|
2 Participants
|
8 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Ventricular tachycardia
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Ear pain
|
0 Participants
|
3 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Hearing impaired
|
0 Participants
|
2 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Tinnitus
|
1 Participants
|
4 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Hyperthyroidism
|
0 Participants
|
3 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Hypothyroidism
|
3 Participants
|
18 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Blurred vision
|
1 Participants
|
2 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Cataract
|
0 Participants
|
2 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Cataract
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Eye pain
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Keratitis
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Diverticulitis
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Gingivitis
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Inguinal Hernia
|
0 Participants
|
2 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Odynophagia
|
0 Participants
|
3 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Oral cavity ulcer
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Abdominal distension
|
0 Participants
|
2 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Abdominal pain
|
2 Participants
|
5 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Abdominal pain
|
0 Participants
|
2 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Ascites
|
0 Participants
|
2 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Bloating
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Colitis
|
0 Participants
|
2 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Colonic obstruction
|
0 Participants
|
2 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Constipation
|
1 Participants
|
15 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Dental caries
|
1 Participants
|
0 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Diarrhea
|
1 Participants
|
15 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Dry mouth
|
1 Participants
|
13 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Dysphagia
|
2 Participants
|
13 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Esophageal perforation
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Gastritis
|
0 Participants
|
2 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Gastroesophageal reflux disease
|
1 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Hematemesis
|
1 Participants
|
0 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Ileus
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Mucositis oral
|
0 Participants
|
5 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Mucositis oral
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Nausea
|
1 Participants
|
15 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Nausea
|
1 Participants
|
2 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Oral cavity fistula
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Oral hemorrhage
|
0 Participants
|
2 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Oral hemorrhage
|
0 Participants
|
3 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Oral pain
|
0 Participants
|
4 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Pancreatitis
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Small intestinal obstruction
|
0 Participants
|
2 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Vomiting
|
2 Participants
|
5 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Vomiting
|
0 Participants
|
2 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Sudden death NOS
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Death NOS
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Death due to disease progression
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Chills
|
0 Participants
|
4 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Edema face
|
0 Participants
|
3 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Edema limbs
|
2 Participants
|
8 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Edema limbs
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Facial pain
|
0 Participants
|
4 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Fatigue
|
1 Participants
|
28 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Fatigue
|
2 Participants
|
3 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Fever
|
2 Participants
|
3 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Fever
|
1 Participants
|
0 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Flu like symptoms
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Infusion related reaction
|
0 Participants
|
5 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Infusion related reaction
|
0 Participants
|
2 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Localized edema
|
0 Participants
|
2 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Malaise
|
2 Participants
|
4 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Neck edema
|
0 Participants
|
4 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Non-cardiac chest pain
|
1 Participants
|
3 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Pain
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Transaminitis
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 COVID-19
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 COVID-19
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Oral candidiasis
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Bronchial infection
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Hepatitis viral
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Laryngitis
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Lung infection
|
1 Participants
|
11 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Peritoneal infection
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Sepsis
|
0 Participants
|
3 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Sinusitis
|
0 Participants
|
2 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Skin infection
|
0 Participants
|
4 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Tooth infection
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Upper respiratory infection
|
1 Participants
|
3 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Upper respiratory infection
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Urinary tract infection
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Catheter related infection
|
1 Participants
|
0 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Wound infection
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Bruising
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Fall
|
0 Participants
|
4 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Postoperative thoracic procedure complication
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Tracheal hemorrhage
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Wound dehiscence
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Activated partial thromboplastin time prolonged
|
1 Participants
|
3 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Activated partial thromboplastin time prolonged
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Alanine aminotransferase increased
|
2 Participants
|
8 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Alkaline phosphatase increased
|
2 Participants
|
9 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Aspartate aminotransferase increased
|
3 Participants
|
15 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Blood bilirubin increased
|
1 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Blood bilirubin increased
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Cardiac troponin I increased
|
1 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Cardiac troponin I increased
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Cardiac troponin T increased
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Cholesterol high
|
0 Participants
|
3 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Creatinine increased
|
0 Participants
|
20 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Creatinine increased
|
1 Participants
|
0 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 INR increased
|
1 Participants
|
8 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 INR increased
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Lipase increased
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Lipase increased
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Lymphocyte count decreased
|
0 Participants
|
24 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Lymphocyte count decreased
|
3 Participants
|
10 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Neutrophil count decreased
|
1 Participants
|
5 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Platelet count decreased
|
2 Participants
|
13 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Platelet count decreased
|
1 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Serum amylase increased
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Serum amylase increased
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 GGT increased
|
1 Participants
|
0 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Weight loss
|
3 Participants
|
15 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Weight loss
|
0 Participants
|
6 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 White blood cell decreased
|
1 Participants
|
11 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Acidosis
|
2 Participants
|
3 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Acidosis
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Anorexia
|
1 Participants
|
10 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Anorexia
|
0 Participants
|
2 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Dehydration
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Dehydration
|
0 Participants
|
2 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Glucose intolerance
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Hypercalcemia
|
1 Participants
|
8 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Hyperglycemia
|
0 Participants
|
9 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Hyperglycemia
|
0 Participants
|
2 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Hyperkalemia
|
1 Participants
|
15 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Hyperkalemia
|
0 Participants
|
2 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Hypermagnesemia
|
0 Participants
|
4 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Hypernatremia
|
1 Participants
|
3 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Hypertriglyceridemia
|
1 Participants
|
5 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Hypoalbuminemia
|
2 Participants
|
20 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Hypoalbuminemia
|
0 Participants
|
2 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Hypocalcemia
|
1 Participants
|
12 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Hypocalcemia
|
1 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Hypoglycemia
|
0 Participants
|
8 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Hypokalemia
|
0 Participants
|
7 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Hypokalemia
|
1 Participants
|
2 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Hypomagnesemia
|
1 Participants
|
5 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Hyponatremia
|
2 Participants
|
18 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Hyponatremia
|
0 Participants
|
5 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Hypophosphatemia
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Hypophosphatemia
|
2 Participants
|
9 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Bursitis
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Jaw pain
|
0 Participants
|
2 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Mandibular pain
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Shoulder pain
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Arthralgia
|
0 Participants
|
4 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Back pain
|
0 Participants
|
5 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Generalized muscle weakness
|
0 Participants
|
5 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Kyphosis
|
1 Participants
|
2 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Myalgia
|
1 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Neck pain
|
1 Participants
|
5 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Neck pain
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Osteonecrosis of jaw
|
0 Participants
|
2 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Pain in extremity
|
0 Participants
|
2 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Superficial soft tissue fibrosis
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Trismus
|
0 Participants
|
5 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Hemangioma
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Tumor pain
|
0 Participants
|
8 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Tumor pain
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Bell's palsy
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Aphonia
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Dizziness
|
1 Participants
|
9 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Dysarthria
|
0 Participants
|
6 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Dysgeusia
|
1 Participants
|
8 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Encephalopathy
|
0 Participants
|
2 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Headache
|
2 Participants
|
16 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Ischemia cerebrovascular
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Peripheral sensory neuropathy
|
0 Participants
|
6 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Somnolence
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Stroke
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Syncope
|
0 Participants
|
2 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Syncope
|
0 Participants
|
3 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Agitation
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Anxiety
|
0 Participants
|
3 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Confusion
|
2 Participants
|
2 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Depression
|
1 Participants
|
7 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Hallucinations
|
0 Participants
|
2 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Insomnia
|
0 Participants
|
3 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Pneumocephalus
|
1 Participants
|
0 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Suicidal ideation
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Kidney stones
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Acute kidney injury
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Acute kidney injury
|
1 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Chronic kidney disease
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Hematuria
|
1 Participants
|
7 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Hematuria
|
1 Participants
|
6 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Proteinuria
|
1 Participants
|
23 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Proteinuria
|
1 Participants
|
6 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Renal colic
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Urinary retention
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Urine discoloration
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Genital edema
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Gynecomastia
|
1 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Hemoptysis
|
2 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Pneumonia
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Tracheal obstruction
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Allergic rhinitis
|
0 Participants
|
2 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Aspiration
|
0 Participants
|
2 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Aspiration
|
1 Participants
|
2 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Atelectasis
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Cough
|
2 Participants
|
12 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Dyspnea
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Epistaxis
|
0 Participants
|
4 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Hoarseness
|
2 Participants
|
7 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Hypoxia
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Laryngeal hemorrhage
|
2 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Pharyngeal fistula
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Pleural effusion
|
0 Participants
|
2 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Dry skin
|
1 Participants
|
17 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 3/4/5 Tracheal fistula
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Rash acneiform
|
0 Participants
|
2 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Rash maculo-papular
|
1 Participants
|
3 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Skin hyperpigmentation
|
0 Participants
|
1 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Skin ulceration
|
0 Participants
|
2 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Telangiectasia
|
0 Participants
|
2 Participants
|
|
Adverse Event Profile of the Combination of Ramucirumab and Pembrolizumab (Phase I and II Participants) as Measured by the Frequency of Adverse Events
Grade 1/2 Hypertension
|
2 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Through completion of follow-up (median length of follow-up of 445 days, full range 14-2240 days)Population: Only participants who had CR or PR in Phase II were evaluable for this outcome measure
-Duration of response: The duration of response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).
Outcome measures
| Measure |
Phase I Dose Level 1 : Ramucirumab (10 mg/kg) + Pembrolizumab
n=18 Participants
Participants enrolled in Phase I Dose Level 1 received 10 mg/kg ramucirumab administered intravenously (IV) on Day 1. Pembrolizumab was administered as per standard of care (SOC) IV at a dose of 200 mg on Day 1. Each cycle was 21 days.
|
Phase II: Ramucirumab (10 mg/kg) + Pembrolizumab
Participants enrolled in the Phase II portion received 10 mg/kg intravenous ramucirumab which was the recommended phase 2 dose (RP2D) determined during the Phase I portion on Day 1. Pembrolizumab was administered as per standard of care (SOC) IV at a dose of 200 mg on Day 1. Each cycle was 21 days.
|
|---|---|---|
|
Duration of Response (Phase II Participants Only)
|
14.0 months
Interval 7.8 to 33.6
|
—
|
SECONDARY outcome
Timeframe: Through completion of follow-up (median length of follow-up of 445 days, full range 14-2240 days)Population: Three participants were not evaluable for this outcome measure.
* PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. * Progressive disease: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
Outcome measures
| Measure |
Phase I Dose Level 1 : Ramucirumab (10 mg/kg) + Pembrolizumab
n=37 Participants
Participants enrolled in Phase I Dose Level 1 received 10 mg/kg ramucirumab administered intravenously (IV) on Day 1. Pembrolizumab was administered as per standard of care (SOC) IV at a dose of 200 mg on Day 1. Each cycle was 21 days.
|
Phase II: Ramucirumab (10 mg/kg) + Pembrolizumab
Participants enrolled in the Phase II portion received 10 mg/kg intravenous ramucirumab which was the recommended phase 2 dose (RP2D) determined during the Phase I portion on Day 1. Pembrolizumab was administered as per standard of care (SOC) IV at a dose of 200 mg on Day 1. Each cycle was 21 days.
|
|---|---|---|
|
Kaplan-Meier Estimate of Median Progression-free Survival (PFS) (Phase II Participants Only)
|
5.6 months
Interval 3.3 to 13.5
|
—
|
SECONDARY outcome
Timeframe: Through completion of follow-up (median length of follow-up of 445 days, full range 14-2240 days)Population: Three participants were not evaluable for this outcome measure.
OS is defined as the duration of time from start of treatment to time of death (or last follow-up alive).
Outcome measures
| Measure |
Phase I Dose Level 1 : Ramucirumab (10 mg/kg) + Pembrolizumab
n=37 Participants
Participants enrolled in Phase I Dose Level 1 received 10 mg/kg ramucirumab administered intravenously (IV) on Day 1. Pembrolizumab was administered as per standard of care (SOC) IV at a dose of 200 mg on Day 1. Each cycle was 21 days.
|
Phase II: Ramucirumab (10 mg/kg) + Pembrolizumab
Participants enrolled in the Phase II portion received 10 mg/kg intravenous ramucirumab which was the recommended phase 2 dose (RP2D) determined during the Phase I portion on Day 1. Pembrolizumab was administered as per standard of care (SOC) IV at a dose of 200 mg on Day 1. Each cycle was 21 days.
|
|---|---|---|
|
Kaplan-Meier Estimate of Median Overall Survival (OS) (Phase II Participants Only)
|
14.8 months
Interval 7.6 to 30.0
|
—
|
SECONDARY outcome
Timeframe: Baseline, start of cycle 2 (each cycle is 21 days), and start of cycle 5 (estimated to be 12 weeks)Population: If a participant did not complete the questionnaire at the specified time point then the participant is not included in the number analyzed.
* Includes 39 questions: 7 in physical well-being, 6 in emotional well-being, 7 in functional well-being, and 12 in head \& neck * Scored from 0 (not at all) to 4 (very much) * Higher scores indicated worse physical and emotional well-being and better social/family and functional well-being * The FACT-H\&N Total Score (range 0-148) measures the sum of the physical, social, emotional, functional, and HNCS domains * The maximum score of 148 reflects the best quality of life.
Outcome measures
| Measure |
Phase I Dose Level 1 : Ramucirumab (10 mg/kg) + Pembrolizumab
n=37 Participants
Participants enrolled in Phase I Dose Level 1 received 10 mg/kg ramucirumab administered intravenously (IV) on Day 1. Pembrolizumab was administered as per standard of care (SOC) IV at a dose of 200 mg on Day 1. Each cycle was 21 days.
|
Phase II: Ramucirumab (10 mg/kg) + Pembrolizumab
Participants enrolled in the Phase II portion received 10 mg/kg intravenous ramucirumab which was the recommended phase 2 dose (RP2D) determined during the Phase I portion on Day 1. Pembrolizumab was administered as per standard of care (SOC) IV at a dose of 200 mg on Day 1. Each cycle was 21 days.
|
|---|---|---|
|
Changes in Quality of Life as Measured by Functional Assessment of Cancer Therapy-Head and Neck (FACT-H&N) (Phase II Participants Only)
Baseline
|
95 score on a scale
Interval 72.0 to 116.0
|
—
|
|
Changes in Quality of Life as Measured by Functional Assessment of Cancer Therapy-Head and Neck (FACT-H&N) (Phase II Participants Only)
Start of cycle 2
|
95 score on a scale
Interval 73.0 to 122.0
|
—
|
|
Changes in Quality of Life as Measured by Functional Assessment of Cancer Therapy-Head and Neck (FACT-H&N) (Phase II Participants Only)
Start of cycle 5
|
108 score on a scale
Interval 89.0 to 127.0
|
—
|
SECONDARY outcome
Timeframe: Baseline, start of cycle 2 (each cycle is 21 days), and start of cycle 5 (estimated to be 12 weeks)Population: If a participant did not complete the questionnaire at the specified time point then the participant is not included in the number analyzed.
* Includes 39 questions: 7 in physical well-being, 6 in emotional well-being, 7 in functional well-being, and 12 in head \& neck * Scored from 0 (not at all) to 4 (very much) * Higher scores indicated worse physical and emotional well-being and better social/family and functional well-being * The FACT-H\&N TOI (range 0-96) measures the total score for the physical, functional, and HNCS domains but excludes the emotional and social domains * The maximum score of 96 reflects the best quality of life.
Outcome measures
| Measure |
Phase I Dose Level 1 : Ramucirumab (10 mg/kg) + Pembrolizumab
n=37 Participants
Participants enrolled in Phase I Dose Level 1 received 10 mg/kg ramucirumab administered intravenously (IV) on Day 1. Pembrolizumab was administered as per standard of care (SOC) IV at a dose of 200 mg on Day 1. Each cycle was 21 days.
|
Phase II: Ramucirumab (10 mg/kg) + Pembrolizumab
Participants enrolled in the Phase II portion received 10 mg/kg intravenous ramucirumab which was the recommended phase 2 dose (RP2D) determined during the Phase I portion on Day 1. Pembrolizumab was administered as per standard of care (SOC) IV at a dose of 200 mg on Day 1. Each cycle was 21 days.
|
|---|---|---|
|
Changes in Quality of Life as Measured by Functional Assessment of Cancer Therapy-Head and Neck Trial Outcome Index (FACT-H&N TOI) (Phase II Participants Only)
Start of cycle 2
|
53 score on a scale
Interval 38.0 to 76.0
|
—
|
|
Changes in Quality of Life as Measured by Functional Assessment of Cancer Therapy-Head and Neck Trial Outcome Index (FACT-H&N TOI) (Phase II Participants Only)
Baseline
|
55 score on a scale
Interval 40.0 to 74.0
|
—
|
|
Changes in Quality of Life as Measured by Functional Assessment of Cancer Therapy-Head and Neck Trial Outcome Index (FACT-H&N TOI) (Phase II Participants Only)
Start of cycle 5
|
64 score on a scale
Interval 49.0 to 81.0
|
—
|
SECONDARY outcome
Timeframe: Baseline, start of cycle 2 (each cycle is 21 days), and start of cycle 5 (estimated to be 12 weeks)Population: If a participant did not complete the questionnaire at the specified time point then the participant is not included in the number analyzed.
* Includes 27 questions: 7 in physical well-being, 6 in emotional well-being, 7 in functional well-being, 7 in social well-being. * Scored from 0 (not at all) to 4 (very much) * Higher scores indicated worse physical and emotional well-being and better social/family and functional well-being * The FACT-G Total Score (range 0-108) measures the sum of the physical, social, emotional, and functional domains but excludes the HNCS domain * The maximum score of 108 reflects the best quality of life.
Outcome measures
| Measure |
Phase I Dose Level 1 : Ramucirumab (10 mg/kg) + Pembrolizumab
n=37 Participants
Participants enrolled in Phase I Dose Level 1 received 10 mg/kg ramucirumab administered intravenously (IV) on Day 1. Pembrolizumab was administered as per standard of care (SOC) IV at a dose of 200 mg on Day 1. Each cycle was 21 days.
|
Phase II: Ramucirumab (10 mg/kg) + Pembrolizumab
Participants enrolled in the Phase II portion received 10 mg/kg intravenous ramucirumab which was the recommended phase 2 dose (RP2D) determined during the Phase I portion on Day 1. Pembrolizumab was administered as per standard of care (SOC) IV at a dose of 200 mg on Day 1. Each cycle was 21 days.
|
|---|---|---|
|
Changes in Quality of Life as Measured by Functional Assessment of Cancer Therapy-General (FACT-G) (Phase II Participants Only)
Baseline
|
75 score on a scale
Interval 61.0 to 92.0
|
—
|
|
Changes in Quality of Life as Measured by Functional Assessment of Cancer Therapy-General (FACT-G) (Phase II Participants Only)
Start of cycle 5
|
85 score on a scale
Interval 70.0 to 99.0
|
—
|
|
Changes in Quality of Life as Measured by Functional Assessment of Cancer Therapy-General (FACT-G) (Phase II Participants Only)
Start of cycle 2
|
71 score on a scale
Interval 63.0 to 92.0
|
—
|
SECONDARY outcome
Timeframe: Baseline, start of cycle 2 (each cycle is 21 days), and start of cycle 5 (estimated to be 12 weeks)Population: If a participant did not complete the questionnaire at the specified time point then the participant is not included in the number analyzed.
EORTC QLQ-C30: this has a total score, one general quality of life (QoL), and one "within the last week" subscale, as well as a general health item and a single overall QoL item. This study does not use current empirical guidelines for the EORTC-QLQ-30 global score with the understanding that both the magnitude and variance of scores vary considerably from patient to patient, from one time point to another and by such factors as disease condition, age, and comorbidity. The participants can choose from 1-4 with 1 being Not At All and 4 being Very Much. A high scale score represents a higher response level but these differ based on the type of sub-scale. Per the QLQ-C30 scoring manual, a high score for the global health status / QoL represents a high QoL, The total score range was 0-100.
Outcome measures
| Measure |
Phase I Dose Level 1 : Ramucirumab (10 mg/kg) + Pembrolizumab
n=37 Participants
Participants enrolled in Phase I Dose Level 1 received 10 mg/kg ramucirumab administered intravenously (IV) on Day 1. Pembrolizumab was administered as per standard of care (SOC) IV at a dose of 200 mg on Day 1. Each cycle was 21 days.
|
Phase II: Ramucirumab (10 mg/kg) + Pembrolizumab
Participants enrolled in the Phase II portion received 10 mg/kg intravenous ramucirumab which was the recommended phase 2 dose (RP2D) determined during the Phase I portion on Day 1. Pembrolizumab was administered as per standard of care (SOC) IV at a dose of 200 mg on Day 1. Each cycle was 21 days.
|
|---|---|---|
|
Changes in Quality of Life as Measured by The European Organisation for Research and Treatment of Cancer Core Questionnaire (EORTC QLQ-30) - Global Health Status (Phase II Participants Only)
Baseline
|
58.3 score on a scale
Interval 50.0 to 83.3
|
—
|
|
Changes in Quality of Life as Measured by The European Organisation for Research and Treatment of Cancer Core Questionnaire (EORTC QLQ-30) - Global Health Status (Phase II Participants Only)
Start of cycle 2
|
58.3 score on a scale
Interval 50.0 to 66.7
|
—
|
|
Changes in Quality of Life as Measured by The European Organisation for Research and Treatment of Cancer Core Questionnaire (EORTC QLQ-30) - Global Health Status (Phase II Participants Only)
Start of cycle 5
|
66.7 score on a scale
Interval 50.0 to 75.0
|
—
|
SECONDARY outcome
Timeframe: Baseline, start of cycle 2 (each cycle is 21 days), and start of cycle 5 (estimated to be 12 weeks)Population: If a participant did not complete the questionnaire at the specified time point then the participant is not included in the number analyzed.
EORTC QLQ-C30: this has a total score, one general quality of life (QoL), and one "within the last week" subscale, as well as a general health item and a single overall QoL item. This study does not use current empirical guidelines for the EORTC-QLQ-30 global score with the understanding that both the magnitude and variance of scores vary considerably from patient to patient, from one time point to another and by such factors as disease condition, age, and comorbidity. The participants can choose from 1-4 with 1 being Not At All and 4 being Very Much. A high scale score represents a higher response level but these differ based on the type of sub-scale. Per the QLQ-C30 scoring manual, high score for a functional scale represents a high / healthy level of functioning. The total score range was 0-100.
Outcome measures
| Measure |
Phase I Dose Level 1 : Ramucirumab (10 mg/kg) + Pembrolizumab
n=37 Participants
Participants enrolled in Phase I Dose Level 1 received 10 mg/kg ramucirumab administered intravenously (IV) on Day 1. Pembrolizumab was administered as per standard of care (SOC) IV at a dose of 200 mg on Day 1. Each cycle was 21 days.
|
Phase II: Ramucirumab (10 mg/kg) + Pembrolizumab
Participants enrolled in the Phase II portion received 10 mg/kg intravenous ramucirumab which was the recommended phase 2 dose (RP2D) determined during the Phase I portion on Day 1. Pembrolizumab was administered as per standard of care (SOC) IV at a dose of 200 mg on Day 1. Each cycle was 21 days.
|
|---|---|---|
|
Changes in Quality of Life as Measured by The European Organisation for Research and Treatment of Cancer Core Questionnaire (EORTC QLQ-30) - Functional Scale (Phase II Participants Only)
Start of cycle 5
|
85.5 score on a scale
Interval 71.7 to 93.3
|
—
|
|
Changes in Quality of Life as Measured by The European Organisation for Research and Treatment of Cancer Core Questionnaire (EORTC QLQ-30) - Functional Scale (Phase II Participants Only)
Baseline
|
76.3 score on a scale
Interval 61.0 to 96.7
|
—
|
|
Changes in Quality of Life as Measured by The European Organisation for Research and Treatment of Cancer Core Questionnaire (EORTC QLQ-30) - Functional Scale (Phase II Participants Only)
Start of cycle 2
|
78.3 score on a scale
Interval 66.3 to 93.7
|
—
|
SECONDARY outcome
Timeframe: Baseline, start of cycle 2 (each cycle is 21 days), and start of cycle 5 (estimated to be 12 weeks)Population: If a participant did not complete the questionnaire at the specified time point then the participant is not included in the number analyzed.
EORTC QLQ-C30: this has a total score, one general quality of life (QoL), and one "within the last week" subscale, as well as a general health item and a single overall QoL item. This study does not use current empirical guidelines for the EORTC-QLQ-30 global score with the understanding that both the magnitude and variance of scores vary considerably from patient to patient, from one time point to another and by such factors as disease condition, age, and comorbidity. The participants can choose from 1-4 with 1 being Not At All and 4 being Very Much. A high scale score represents a higher response level but these differ based on the type of sub-scale. Per the QLQ-C30 scoring manual, a high score for a symptom scale / item represents a high level of symptomatology / problems. The total score range was 0-100.
Outcome measures
| Measure |
Phase I Dose Level 1 : Ramucirumab (10 mg/kg) + Pembrolizumab
n=37 Participants
Participants enrolled in Phase I Dose Level 1 received 10 mg/kg ramucirumab administered intravenously (IV) on Day 1. Pembrolizumab was administered as per standard of care (SOC) IV at a dose of 200 mg on Day 1. Each cycle was 21 days.
|
Phase II: Ramucirumab (10 mg/kg) + Pembrolizumab
Participants enrolled in the Phase II portion received 10 mg/kg intravenous ramucirumab which was the recommended phase 2 dose (RP2D) determined during the Phase I portion on Day 1. Pembrolizumab was administered as per standard of care (SOC) IV at a dose of 200 mg on Day 1. Each cycle was 21 days.
|
|---|---|---|
|
Changes in Quality of Life as Measured by The European Organisation for Research and Treatment of Cancer Core Questionnaire (EORTC QLQ-30) - Symptom Scale (Phase II Participants Only)
Start of cycle 2
|
21.6 score on a scale
Interval 11.1 to 32.7
|
—
|
|
Changes in Quality of Life as Measured by The European Organisation for Research and Treatment of Cancer Core Questionnaire (EORTC QLQ-30) - Symptom Scale (Phase II Participants Only)
Start of cycle 5
|
17 score on a scale
Interval 7.4 to 25.3
|
—
|
|
Changes in Quality of Life as Measured by The European Organisation for Research and Treatment of Cancer Core Questionnaire (EORTC QLQ-30) - Symptom Scale (Phase II Participants Only)
Baseline
|
24.7 score on a scale
Interval 6.2 to 37.7
|
—
|
Adverse Events
Phase I Dose Level 1 : Ramucirumab (10 mg/kg) + Pembrolizumab
Serious events: 2 serious events
Other events: 3 other events
Deaths: 3 deaths
Phase II: Ramucirumab (10 mg/kg) + Pembrolizumab
Serious events: 26 serious events
Other events: 37 other events
Deaths: 32 deaths
Serious adverse events
| Measure |
Phase I Dose Level 1 : Ramucirumab (10 mg/kg) + Pembrolizumab
n=3 participants at risk
Participants enrolled in Phase I Dose Level 1 received 10 mg/kg ramucirumab administered intravenously (IV) on Day 1. Pembrolizumab was administered as per standard of care (SOC) IV at a dose of 200 mg on Day 1. Each cycle was 21 days.
|
Phase II: Ramucirumab (10 mg/kg) + Pembrolizumab
n=37 participants at risk
Participants enrolled in the Phase II portion received 10 mg/kg intravenous ramucirumab which was the recommended phase 2 dose (RP2D) determined during the Phase I portion on Day 1. Pembrolizumab was administered as per standard of care (SOC) IV at a dose of 200 mg on Day 1. Each cycle was 21 days.
|
|---|---|---|
|
Blood and lymphatic system disorders
Hemolytic uremic syndrome
|
33.3%
1/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
0.00%
0/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
5.4%
2/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Gastrointestinal disorders
Diverticulitis
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
8.1%
3/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Gastrointestinal disorders
Esophageal perforation
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
5.4%
2/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
10.8%
4/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
General disorders
Death NOS
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
General disorders
Death due to disease progression
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
8.1%
3/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
General disorders
Flu like symptoms
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
General disorders
Infusion related reaction
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
5.4%
2/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
General disorders
Sudden death NOS
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Hepatobiliary disorders
Transaminitis
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Infections and infestations
COVID-19
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Infections and infestations
Catheter related infection
|
33.3%
1/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
0.00%
0/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
27.0%
10/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Infections and infestations
Peritoneal infection
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
8.1%
3/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Infections and infestations
Wound infection
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Injury, poisoning and procedural complications
Postoperative thoracic procedure complication
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
5.4%
2/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Nervous system disorders
Ischemia cerebrovascular
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Nervous system disorders
Pneumocephalus
|
33.3%
1/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
0.00%
0/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
5.4%
2/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
5.4%
2/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal hemorrhage
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
8.1%
3/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
Other adverse events
| Measure |
Phase I Dose Level 1 : Ramucirumab (10 mg/kg) + Pembrolizumab
n=3 participants at risk
Participants enrolled in Phase I Dose Level 1 received 10 mg/kg ramucirumab administered intravenously (IV) on Day 1. Pembrolizumab was administered as per standard of care (SOC) IV at a dose of 200 mg on Day 1. Each cycle was 21 days.
|
Phase II: Ramucirumab (10 mg/kg) + Pembrolizumab
n=37 participants at risk
Participants enrolled in the Phase II portion received 10 mg/kg intravenous ramucirumab which was the recommended phase 2 dose (RP2D) determined during the Phase I portion on Day 1. Pembrolizumab was administered as per standard of care (SOC) IV at a dose of 200 mg on Day 1. Each cycle was 21 days.
|
|---|---|---|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
5.4%
2/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
5.4%
2/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
40.5%
15/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Gastrointestinal disorders
Dental caries
|
33.3%
1/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
0.00%
0/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
40.5%
15/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Gastrointestinal disorders
Dry mouth
|
33.3%
1/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
35.1%
13/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Gastrointestinal disorders
Dysphagia
|
100.0%
3/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
64.9%
24/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
33.3%
1/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Gastrointestinal disorders
Gingivitis
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Gastrointestinal disorders
Hematemesis
|
33.3%
1/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
0.00%
0/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
5.4%
2/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
13.5%
5/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Cardiac disorders
Sinus tachycardia
|
66.7%
2/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
21.6%
8/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
8.1%
3/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
5.4%
2/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Ear and labyrinth disorders
Tinnitus
|
33.3%
1/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
10.8%
4/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
8.1%
3/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Endocrine disorders
Hypothyroidism
|
100.0%
3/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
48.6%
18/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Eye disorders
Blurred vision
|
33.3%
1/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
5.4%
2/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Eye disorders
Cataract
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
8.1%
3/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Eye disorders
Eye pain
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Eye disorders
Keratitis
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Gastrointestinal disorders
Abdominal distention
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
5.4%
2/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Gastrointestinal disorders
Abdominal pain
|
66.7%
2/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
16.2%
6/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
2/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
97.3%
36/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
16.2%
6/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
43.2%
16/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
8.1%
3/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Gastrointestinal disorders
Oral cavity fistula
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Gastrointestinal disorders
Oral cavity ulcer
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
10.8%
4/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
5.4%
2/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
2/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
18.9%
7/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
General disorders
Chills
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
10.8%
4/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
General disorders
Edema face
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
8.1%
3/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
General disorders
Edema limbs
|
66.7%
2/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
24.3%
9/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
General disorders
Facial pain
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
10.8%
4/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
General disorders
Fatigue
|
100.0%
3/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
83.8%
31/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
General disorders
Fever
|
100.0%
3/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
8.1%
3/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
General disorders
Infusion related reaction
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
13.5%
5/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
General disorders
Localized edema
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
5.4%
2/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
General disorders
Malaise
|
66.7%
2/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
10.8%
4/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
General disorders
Neck edema
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
10.8%
4/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
General disorders
Non-cardiac chest pain
|
33.3%
1/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
8.1%
3/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
General disorders
Pain
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Infections and infestations
COVID-19
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Infections and infestations
Hepatitis viral
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Infections and infestations
Lung infection
|
33.3%
1/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
5.4%
2/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
10.8%
4/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Infections and infestations
Upper respiratory infection
|
33.3%
1/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
8.1%
3/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
10.8%
4/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Injury, poisoning and procedural complications
Tracheal hemorrhage
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
33.3%
1/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
10.8%
4/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Investigations
Alanine aminotransferase increased
|
66.7%
2/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
21.6%
8/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Investigations
Alkaline phosphatase increased
|
66.7%
2/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
24.3%
9/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Investigations
Aspartate aminotransferase increased
|
100.0%
3/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
40.5%
15/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Investigations
Blood bilirubin increased
|
33.3%
1/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
5.4%
2/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Investigations
Cardiac troponin I increased
|
33.3%
1/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
5.4%
2/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Investigations
Cardiac troponin T increased
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Investigations
Cholesterol high
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
8.1%
3/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Investigations
Creatinine increased
|
33.3%
1/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
54.1%
20/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Investigations
GGT increased
|
33.3%
1/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
0.00%
0/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Investigations
INR increased
|
33.3%
1/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
24.3%
9/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Investigations
Lipase increased
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
5.4%
2/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Investigations
Lymphocyte count decreased
|
100.0%
3/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
91.9%
34/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Investigations
Neutrophil count decreased
|
33.3%
1/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
13.5%
5/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Investigations
Platelet count decreased
|
100.0%
3/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
37.8%
14/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Investigations
Serum amylase increased
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
5.4%
2/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Investigations
Weight loss
|
100.0%
3/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
56.8%
21/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Investigations
White blood cell decreased
|
33.3%
1/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
29.7%
11/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Metabolism and nutrition disorders
Acidosis
|
66.7%
2/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
10.8%
4/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
1/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
32.4%
12/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
33.3%
1/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
18.9%
7/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
21.6%
8/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
29.7%
11/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
33.3%
1/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
45.9%
17/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
10.8%
4/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
33.3%
1/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
8.1%
3/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
33.3%
1/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
13.5%
5/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
66.7%
2/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
59.5%
22/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
66.7%
2/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
35.1%
13/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
33.3%
1/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
24.3%
9/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
33.3%
1/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
13.5%
5/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
66.7%
2/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
62.2%
23/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
66.7%
2/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
27.0%
10/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
10.8%
4/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
13.5%
5/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
13.5%
5/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Jaw pain
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Kyphosis
|
33.3%
1/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
5.4%
2/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Mandibular pain
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
1/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
33.3%
1/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
16.2%
6/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
5.4%
2/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
5.4%
2/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Superficial soft tissue fibrosis
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
13.5%
5/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hemangioma
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
24.3%
9/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Nervous system disorders
Aphonia
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Nervous system disorders
Bell's palsy
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
24.3%
9/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
16.2%
6/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Nervous system disorders
Dysgeusia
|
33.3%
1/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
21.6%
8/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
5.4%
2/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Nervous system disorders
Headache
|
66.7%
2/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
43.2%
16/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
16.2%
6/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Nervous system disorders
Stroke
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
8.1%
3/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
8.1%
3/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Psychiatric disorders
Confusion
|
66.7%
2/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
5.4%
2/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Psychiatric disorders
Depression
|
33.3%
1/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
18.9%
7/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
5.4%
2/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
8.1%
3/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Renal and urinary disorders
Hematuria
|
66.7%
2/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
35.1%
13/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Renal and urinary disorders
Kidney stones
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Renal and urinary disorders
Proteinuria
|
66.7%
2/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
78.4%
29/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Renal and urinary disorders
Urine discoloration
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Reproductive system and breast disorders
Genital edema
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Reproductive system and breast disorders
Gynecomastia
|
33.3%
1/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
5.4%
2/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
33.3%
1/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
8.1%
3/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
66.7%
2/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
32.4%
12/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
100.0%
3/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
43.2%
16/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Epiglottitis
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
10.8%
4/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
66.7%
2/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
66.7%
2/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
18.9%
7/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal hemorrhage
|
66.7%
2/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
33.3%
1/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
18.9%
7/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal fistula
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
5.4%
2/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
33.3%
1/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
8.1%
3/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
18.9%
7/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
33.3%
1/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
33.3%
1/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
24.3%
9/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal fistula
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal obstruction
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
5.4%
2/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
33.3%
1/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
45.9%
17/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Skin and subcutaneous tissue disorders
Hemangiomas
|
33.3%
1/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
0.00%
0/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
18.9%
7/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
5.4%
2/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
33.3%
1/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
8.1%
3/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
16.2%
6/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
5.4%
2/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous nodule
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
5.4%
2/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Vascular disorders
Hypertension
|
100.0%
3/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
51.4%
19/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
29.7%
11/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Vascular disorders
Lymphedema
|
33.3%
1/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
13.5%
5/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
5.4%
2/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.00%
0/3 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
2.7%
1/37 • Adverse events were collected from the date of first treatment until 28 days after completion of treatment. Median total time for adverse event collection was 183 days (full range 14-2240 days). All cause mortality were collected from start of enrollment to death or completion of follow up (median total time for all-cause mortality collection was 425 days, full range 14-2240 days).
Participants who were enrolled but did not start treatment were not followed for adverse events or all cause mortality.
|
Additional Information
Dr. Douglas Adkins
Washington University School of Medicine
Phone: 314-747-8475
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place