Trial Outcomes & Findings for Nivolumab Plus Cisplatin/Pemetrexed or Cisplatin/Gemcitabine as Induction in Resectable Non-Small Cell Lung Cancer (NCT NCT03366766)
NCT ID: NCT03366766
Last Updated: 2026-02-20
Results Overview
For the primary endpoint, the major pathologic response rate was calculated as a percentage of patients who achieved a major pathologic response (i.e., \<10% viable tumor) or pathologic complete response. Then, the major pathologic response rate was tested with the exact binomial test under the null hypothesis that the true major pathologic response rate is ≤ 0.19. The corresponding 95% Clopper-Pearson confidence limits were reported too.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
14 participants
Primary outcome timeframe
Up to 63 days
Results posted on
2026-02-20
Participant Flow
Participant milestones
| Measure |
Cohort I (Nivolumab, Cisplatin, Pemetrexed Disodium)
Patients with non-squamous lung cancer receive nivolumab IV over 30 minutes, cisplatin IV over 60-120 minutes, and pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 3 weeks for up to 9 weeks in the absence of disease progression or unacceptable toxicity
Nivolumab: Given IV
Cisplatin: Given IV
Pemetrexed Disodium: Given IV
|
Cohort II (Nivolumab, Cisplatin, Gemcitabine Hydrochloride)
Patients with squamous lung cancer receive nivolumab IV over 30 minutes on day 1, cisplatin IV over 60-120 minutes on day 1, and gemcitabine hydrochloride IV over 1 hour on days 1 and 8. Courses repeat every 3 weeks for up to 9 weeks in the absence of disease progression or unacceptable toxicity.
Nivolumab: Given IV
Gemcitabine Hydrochloride: Given IV
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
10
|
|
Overall Study
COMPLETED
|
4
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nivolumab Plus Cisplatin/Pemetrexed or Cisplatin/Gemcitabine as Induction in Resectable Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Cohort I (Nivolumab, Cisplatin, Pemetrexed Disodium)
n=4 Participants
Patients with non-squamous lung cancer receive nivolumab IV over 30 minutes, cisplatin IV over 60-120 minutes, and pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 3 weeks for up to 9 weeks in the absence of disease progression or unacceptable toxicity
Nivolumab: Given IV
Cisplatin: Given IV
Pemetrexed Disodium: Given IV
|
Cohort II (Nivolumab, Cisplatin, Gemcitabine Hydrochloride)
n=10 Participants
Patients with squamous lung cancer receive nivolumab IV over 30 minutes on day 1, cisplatin IV over 60-120 minutes on day 1, and gemcitabine hydrochloride IV over 1 hour on days 1 and 8. Courses repeat every 3 weeks for up to 9 weeks in the absence of disease progression or unacceptable toxicity.
Nivolumab: Given IV
Gemcitabine Hydrochloride: Given IV
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=29 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=14 Participants
|
10 Participants
n=14 Participants
|
14 Participants
n=29 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=29 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=14 Participants
|
4 Participants
n=14 Participants
|
7 Participants
n=29 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=14 Participants
|
6 Participants
n=14 Participants
|
7 Participants
n=29 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=29 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=14 Participants
|
10 Participants
n=14 Participants
|
14 Participants
n=29 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=29 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=29 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=14 Participants
|
2 Participants
n=14 Participants
|
2 Participants
n=29 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=29 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=29 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=14 Participants
|
8 Participants
n=14 Participants
|
11 Participants
n=29 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
1 Participants
n=29 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=29 Participants
|
PRIMARY outcome
Timeframe: Up to 63 daysPopulation: The primary endpoint was pre-scpecified in the protocol to be analyzed collectively. This outcome was intended to be evaluated across all participants together, not by individual regimen, so the arms were combined for this analysis.
For the primary endpoint, the major pathologic response rate was calculated as a percentage of patients who achieved a major pathologic response (i.e., \<10% viable tumor) or pathologic complete response. Then, the major pathologic response rate was tested with the exact binomial test under the null hypothesis that the true major pathologic response rate is ≤ 0.19. The corresponding 95% Clopper-Pearson confidence limits were reported too.
Outcome measures
| Measure |
Cohort I (Nivolumab, Cisplatin, Pemetrexed Disodium)
n=4 Participants
Patients with non-squamous lung cancer receive nivolumab IV over 30 minutes, cisplatin IV over 60-120 minutes, and pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 3 weeks for up to 9 weeks in the absence of disease progression or unacceptable toxicity Nivolumab: Given IV Cisplatin: Given IV Pemetrexed Disodium: Given IV
|
Cohort II (Nivolumab, Cisplatin, Gemcitabine Hydrochloride)
n=10 Participants
Patients with squamous lung cancer receive nivolumab IV over 30 minutes on day 1, cisplatin IV over 60-120 minutes on day 1, and gemcitabine hydrochloride IV over 1 hour on days 1 and 8. Courses repeat every 3 weeks for up to 9 weeks in the absence of disease progression or unacceptable toxicity.
Nivolumab: Given IV Gemcitabine Hydrochloride: Given IV
|
Combined Cohort (All Patient Receiving Nivolumab IV
n=14 Participants
Cohort I: Patients with non-squamous lung cancer receive nivolumab IV over 30 minutes, cisplatin IV over 60-120 minutes, and pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 3 weeks for up to 9 weeks in the absence of disease progression or unacceptable toxicity
Nivolumab: Given IV
Cisplatin: Given IV
Pemetrexed Disodium: Given IV
Cohort II: Patients with squamous lung cancer receive nivolumab IV over 30 minutes on day 1, cisplatin IV over 60-120 minutes on day 1, and gemcitabine hydrochloride IV over 1 hour on days 1 and 8. Courses repeat every 3 weeks for up to 9 weeks in the absence of disease progression or unacceptable toxicity.
Nivolumab: Given IV
Gemcitabine Hydrochloride: Given IV
|
|---|---|---|---|
|
Major Pathologic Response (mpCR) Defined as < 10% Viable Tumor
|
75 Percentage of Participants
Interval 19.4 to 99.4
|
80.0 Percentage of Participants
Interval 44.4 to 97.5
|
78.6 Percentage of Participants
Interval 49.2 to 95.3
|
SECONDARY outcome
Timeframe: Up to 6 monthsNumber of adverse events according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Safety data will be summarized descriptively.
Outcome measures
| Measure |
Cohort I (Nivolumab, Cisplatin, Pemetrexed Disodium)
n=4 Participants
Patients with non-squamous lung cancer receive nivolumab IV over 30 minutes, cisplatin IV over 60-120 minutes, and pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 3 weeks for up to 9 weeks in the absence of disease progression or unacceptable toxicity Nivolumab: Given IV Cisplatin: Given IV Pemetrexed Disodium: Given IV
|
Cohort II (Nivolumab, Cisplatin, Gemcitabine Hydrochloride)
n=10 Participants
Patients with squamous lung cancer receive nivolumab IV over 30 minutes on day 1, cisplatin IV over 60-120 minutes on day 1, and gemcitabine hydrochloride IV over 1 hour on days 1 and 8. Courses repeat every 3 weeks for up to 9 weeks in the absence of disease progression or unacceptable toxicity.
Nivolumab: Given IV Gemcitabine Hydrochloride: Given IV
|
Combined Cohort (All Patient Receiving Nivolumab IV
Cohort I: Patients with non-squamous lung cancer receive nivolumab IV over 30 minutes, cisplatin IV over 60-120 minutes, and pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 3 weeks for up to 9 weeks in the absence of disease progression or unacceptable toxicity
Nivolumab: Given IV
Cisplatin: Given IV
Pemetrexed Disodium: Given IV
Cohort II: Patients with squamous lung cancer receive nivolumab IV over 30 minutes on day 1, cisplatin IV over 60-120 minutes on day 1, and gemcitabine hydrochloride IV over 1 hour on days 1 and 8. Courses repeat every 3 weeks for up to 9 weeks in the absence of disease progression or unacceptable toxicity.
Nivolumab: Given IV
Gemcitabine Hydrochloride: Given IV
|
|---|---|---|---|
|
Number of Adverse Events
|
12 adverse events
|
122 adverse events
|
—
|
SECONDARY outcome
Timeframe: At 1 yearThe distribution of progression-free survival will be estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Cohort I (Nivolumab, Cisplatin, Pemetrexed Disodium)
n=4 Participants
Patients with non-squamous lung cancer receive nivolumab IV over 30 minutes, cisplatin IV over 60-120 minutes, and pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 3 weeks for up to 9 weeks in the absence of disease progression or unacceptable toxicity Nivolumab: Given IV Cisplatin: Given IV Pemetrexed Disodium: Given IV
|
Cohort II (Nivolumab, Cisplatin, Gemcitabine Hydrochloride)
n=10 Participants
Patients with squamous lung cancer receive nivolumab IV over 30 minutes on day 1, cisplatin IV over 60-120 minutes on day 1, and gemcitabine hydrochloride IV over 1 hour on days 1 and 8. Courses repeat every 3 weeks for up to 9 weeks in the absence of disease progression or unacceptable toxicity.
Nivolumab: Given IV Gemcitabine Hydrochloride: Given IV
|
Combined Cohort (All Patient Receiving Nivolumab IV
n=14 Participants
Cohort I: Patients with non-squamous lung cancer receive nivolumab IV over 30 minutes, cisplatin IV over 60-120 minutes, and pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 3 weeks for up to 9 weeks in the absence of disease progression or unacceptable toxicity
Nivolumab: Given IV
Cisplatin: Given IV
Pemetrexed Disodium: Given IV
Cohort II: Patients with squamous lung cancer receive nivolumab IV over 30 minutes on day 1, cisplatin IV over 60-120 minutes on day 1, and gemcitabine hydrochloride IV over 1 hour on days 1 and 8. Courses repeat every 3 weeks for up to 9 weeks in the absence of disease progression or unacceptable toxicity.
Nivolumab: Given IV
Gemcitabine Hydrochloride: Given IV
|
|---|---|---|---|
|
Progression Free Survival
|
1.00 Probability of Survival
Interval 1.0 to 1.0
|
0.9 Probability of Survival
Interval 0.47 to 0.99
|
0.93 Probability of Survival
Interval 0.59 to 0.99
|
SECONDARY outcome
Timeframe: Up to 1 yearThe distribution of overall survival will be estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Cohort I (Nivolumab, Cisplatin, Pemetrexed Disodium)
n=4 Participants
Patients with non-squamous lung cancer receive nivolumab IV over 30 minutes, cisplatin IV over 60-120 minutes, and pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 3 weeks for up to 9 weeks in the absence of disease progression or unacceptable toxicity Nivolumab: Given IV Cisplatin: Given IV Pemetrexed Disodium: Given IV
|
Cohort II (Nivolumab, Cisplatin, Gemcitabine Hydrochloride)
n=10 Participants
Patients with squamous lung cancer receive nivolumab IV over 30 minutes on day 1, cisplatin IV over 60-120 minutes on day 1, and gemcitabine hydrochloride IV over 1 hour on days 1 and 8. Courses repeat every 3 weeks for up to 9 weeks in the absence of disease progression or unacceptable toxicity.
Nivolumab: Given IV Gemcitabine Hydrochloride: Given IV
|
Combined Cohort (All Patient Receiving Nivolumab IV
n=14 Participants
Cohort I: Patients with non-squamous lung cancer receive nivolumab IV over 30 minutes, cisplatin IV over 60-120 minutes, and pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 3 weeks for up to 9 weeks in the absence of disease progression or unacceptable toxicity
Nivolumab: Given IV
Cisplatin: Given IV
Pemetrexed Disodium: Given IV
Cohort II: Patients with squamous lung cancer receive nivolumab IV over 30 minutes on day 1, cisplatin IV over 60-120 minutes on day 1, and gemcitabine hydrochloride IV over 1 hour on days 1 and 8. Courses repeat every 3 weeks for up to 9 weeks in the absence of disease progression or unacceptable toxicity.
Nivolumab: Given IV
Gemcitabine Hydrochloride: Given IV
|
|---|---|---|---|
|
Overall Survival
|
1.00 Probability of Survival
Interval 1.0 to 1.0
|
0.9 Probability of Survival
Interval 0.47 to 0.99
|
0.93 Probability of Survival
Interval 0.59 to 0.99
|
SECONDARY outcome
Timeframe: At Week 10Will be summarized by presence of baseline measurable disease. Overall clinical response measured by Chest CT at 3 timepoints
Outcome measures
| Measure |
Cohort I (Nivolumab, Cisplatin, Pemetrexed Disodium)
n=4 Participants
Patients with non-squamous lung cancer receive nivolumab IV over 30 minutes, cisplatin IV over 60-120 minutes, and pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 3 weeks for up to 9 weeks in the absence of disease progression or unacceptable toxicity Nivolumab: Given IV Cisplatin: Given IV Pemetrexed Disodium: Given IV
|
Cohort II (Nivolumab, Cisplatin, Gemcitabine Hydrochloride)
n=10 Participants
Patients with squamous lung cancer receive nivolumab IV over 30 minutes on day 1, cisplatin IV over 60-120 minutes on day 1, and gemcitabine hydrochloride IV over 1 hour on days 1 and 8. Courses repeat every 3 weeks for up to 9 weeks in the absence of disease progression or unacceptable toxicity.
Nivolumab: Given IV Gemcitabine Hydrochloride: Given IV
|
Combined Cohort (All Patient Receiving Nivolumab IV
n=14 Participants
Cohort I: Patients with non-squamous lung cancer receive nivolumab IV over 30 minutes, cisplatin IV over 60-120 minutes, and pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 3 weeks for up to 9 weeks in the absence of disease progression or unacceptable toxicity
Nivolumab: Given IV
Cisplatin: Given IV
Pemetrexed Disodium: Given IV
Cohort II: Patients with squamous lung cancer receive nivolumab IV over 30 minutes on day 1, cisplatin IV over 60-120 minutes on day 1, and gemcitabine hydrochloride IV over 1 hour on days 1 and 8. Courses repeat every 3 weeks for up to 9 weeks in the absence of disease progression or unacceptable toxicity.
Nivolumab: Given IV
Gemcitabine Hydrochloride: Given IV
|
|---|---|---|---|
|
Overall Clinical Response
Complete Response (CR)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Overall Clinical Response
Partial Response (PR)
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Overall Clinical Response
Stable Disease (SD)
|
2 Participants
|
7 Participants
|
9 Participants
|
|
Overall Clinical Response
Progressive Disease (PD)
|
2 Participants
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: At Month 3Population: Data for one participant in Cohort I and three participants in Cohort II was unavailable for this outcome measure. As a result, these cases could not be included in the analysis.
Will be summarized by presence of baseline measurable disease. Overall clinical response measured by Chest CT at 3 timepoints
Outcome measures
| Measure |
Cohort I (Nivolumab, Cisplatin, Pemetrexed Disodium)
n=3 Participants
Patients with non-squamous lung cancer receive nivolumab IV over 30 minutes, cisplatin IV over 60-120 minutes, and pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 3 weeks for up to 9 weeks in the absence of disease progression or unacceptable toxicity Nivolumab: Given IV Cisplatin: Given IV Pemetrexed Disodium: Given IV
|
Cohort II (Nivolumab, Cisplatin, Gemcitabine Hydrochloride)
n=7 Participants
Patients with squamous lung cancer receive nivolumab IV over 30 minutes on day 1, cisplatin IV over 60-120 minutes on day 1, and gemcitabine hydrochloride IV over 1 hour on days 1 and 8. Courses repeat every 3 weeks for up to 9 weeks in the absence of disease progression or unacceptable toxicity.
Nivolumab: Given IV Gemcitabine Hydrochloride: Given IV
|
Combined Cohort (All Patient Receiving Nivolumab IV
n=10 Participants
Cohort I: Patients with non-squamous lung cancer receive nivolumab IV over 30 minutes, cisplatin IV over 60-120 minutes, and pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 3 weeks for up to 9 weeks in the absence of disease progression or unacceptable toxicity
Nivolumab: Given IV
Cisplatin: Given IV
Pemetrexed Disodium: Given IV
Cohort II: Patients with squamous lung cancer receive nivolumab IV over 30 minutes on day 1, cisplatin IV over 60-120 minutes on day 1, and gemcitabine hydrochloride IV over 1 hour on days 1 and 8. Courses repeat every 3 weeks for up to 9 weeks in the absence of disease progression or unacceptable toxicity.
Nivolumab: Given IV
Gemcitabine Hydrochloride: Given IV
|
|---|---|---|---|
|
Overall Clinical Response
Complete Response (CR)
|
1 Participants
|
3 Participants
|
4 Participants
|
|
Overall Clinical Response
Partial Response (PR)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Overall Clinical Response
Stable Disease (SD)
|
0 Participants
|
4 Participants
|
4 Participants
|
|
Overall Clinical Response
Other
|
2 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: At Month 6Population: Data for one participant in Cohort II was unavailable for this outcome measure. As a result, these cases could not be included in the analysis.
Will be summarized by presence of baseline measurable disease. Overall clinical response measured by Chest CT at 3 timepoints
Outcome measures
| Measure |
Cohort I (Nivolumab, Cisplatin, Pemetrexed Disodium)
n=4 Participants
Patients with non-squamous lung cancer receive nivolumab IV over 30 minutes, cisplatin IV over 60-120 minutes, and pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 3 weeks for up to 9 weeks in the absence of disease progression or unacceptable toxicity Nivolumab: Given IV Cisplatin: Given IV Pemetrexed Disodium: Given IV
|
Cohort II (Nivolumab, Cisplatin, Gemcitabine Hydrochloride)
n=9 Participants
Patients with squamous lung cancer receive nivolumab IV over 30 minutes on day 1, cisplatin IV over 60-120 minutes on day 1, and gemcitabine hydrochloride IV over 1 hour on days 1 and 8. Courses repeat every 3 weeks for up to 9 weeks in the absence of disease progression or unacceptable toxicity.
Nivolumab: Given IV Gemcitabine Hydrochloride: Given IV
|
Combined Cohort (All Patient Receiving Nivolumab IV
n=13 Participants
Cohort I: Patients with non-squamous lung cancer receive nivolumab IV over 30 minutes, cisplatin IV over 60-120 minutes, and pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 3 weeks for up to 9 weeks in the absence of disease progression or unacceptable toxicity
Nivolumab: Given IV
Cisplatin: Given IV
Pemetrexed Disodium: Given IV
Cohort II: Patients with squamous lung cancer receive nivolumab IV over 30 minutes on day 1, cisplatin IV over 60-120 minutes on day 1, and gemcitabine hydrochloride IV over 1 hour on days 1 and 8. Courses repeat every 3 weeks for up to 9 weeks in the absence of disease progression or unacceptable toxicity.
Nivolumab: Given IV
Gemcitabine Hydrochloride: Given IV
|
|---|---|---|---|
|
Overall Clinical Response
Complete Response (CR)
|
0 Participants
|
3 Participants
|
3 Participants
|
|
Overall Clinical Response
Partial Response (PR)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Overall Clinical Response
Stable Disease (SD)
|
2 Participants
|
6 Participants
|
8 Participants
|
|
Overall Clinical Response
Other
|
2 Participants
|
0 Participants
|
2 Participants
|
Adverse Events
Cohort I (Nivolumab, Cisplatin, Pemetrexed Disodium)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort II (Nivolumab, Cisplatin, Gemcitabine Hydrochloride)
Serious events: 1 serious events
Other events: 10 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Cohort I (Nivolumab, Cisplatin, Pemetrexed Disodium)
n=4 participants at risk
Patients with non-squamous lung cancer receive nivolumab IV over 30 minutes, cisplatin IV over 60-120 minutes, and pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 3 weeks for up to 9 weeks in the absence of disease progression or unacceptable toxicity
Nivolumab: Given IV
Cisplatin: Given IV
Pemetrexed Disodium: Given IV
|
Cohort II (Nivolumab, Cisplatin, Gemcitabine Hydrochloride)
n=10 participants at risk
Patients with squamous lung cancer receive nivolumab IV over 30 minutes on day 1, cisplatin IV over 60-120 minutes on day 1, and gemcitabine hydrochloride IV over 1 hour on days 1 and 8. Courses repeat every 3 weeks for up to 9 weeks in the absence of disease progression or unacceptable toxicity.
Nivolumab: Given IV
Gemcitabine Hydrochloride: Given IV
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
Other adverse events
| Measure |
Cohort I (Nivolumab, Cisplatin, Pemetrexed Disodium)
n=4 participants at risk
Patients with non-squamous lung cancer receive nivolumab IV over 30 minutes, cisplatin IV over 60-120 minutes, and pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 3 weeks for up to 9 weeks in the absence of disease progression or unacceptable toxicity
Nivolumab: Given IV
Cisplatin: Given IV
Pemetrexed Disodium: Given IV
|
Cohort II (Nivolumab, Cisplatin, Gemcitabine Hydrochloride)
n=10 participants at risk
Patients with squamous lung cancer receive nivolumab IV over 30 minutes on day 1, cisplatin IV over 60-120 minutes on day 1, and gemcitabine hydrochloride IV over 1 hour on days 1 and 8. Courses repeat every 3 weeks for up to 9 weeks in the absence of disease progression or unacceptable toxicity.
Nivolumab: Given IV
Gemcitabine Hydrochloride: Given IV
|
|---|---|---|
|
Cardiac disorders
tachycardia - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
20.0%
2/10 • Number of events 2 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Ear and labyrinth disorders
Ear discharge - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Ear and labyrinth disorders
hearing impairment - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Eye disorders
Floaters - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Eye disorders
Itchy eyes - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Endocrine disorders
Puffy eyes - Grade 1
|
25.0%
1/4 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
0.00%
0/10 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Eye disorders
Vision changes - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Eye disorders
Watering eyes - Grade 1
|
25.0%
1/4 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Gastrointestinal disorders
Constipation - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
20.0%
2/10 • Number of events 2 • Subjects were followed for an average of 8 months for adverse event data.
|
|
General disorders
Chills - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
20.0%
2/10 • Number of events 2 • Subjects were followed for an average of 8 months for adverse event data.
|
|
General disorders
Drooling - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
General disorders
Dry mouth - - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
20.0%
2/10 • Number of events 2 • Subjects were followed for an average of 8 months for adverse event data.
|
|
General disorders
Dry mouth Grade 3
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
General disorders
Dry mouth - Grade 2
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
General disorders
Fall
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
General disorders
Fatigue - Grade1
|
25.0%
1/4 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
60.0%
6/10 • Number of events 6 • Subjects were followed for an average of 8 months for adverse event data.
|
|
General disorders
Fatigue - Grade 2
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
40.0%
4/10 • Number of events 4 • Subjects were followed for an average of 8 months for adverse event data.
|
|
General disorders
Fatigue - Grade 3
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
General disorders
Gait Disturbance - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
General disorders
Generalized Muscle Weakness - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
20.0%
2/10 • Number of events 2 • Subjects were followed for an average of 8 months for adverse event data.
|
|
General disorders
Generalized muscle weakness - Grade 2
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
20.0%
2/10 • Number of events 2 • Subjects were followed for an average of 8 months for adverse event data.
|
|
General disorders
Headaches - Grade 1
|
25.0%
1/4 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
20.0%
2/10 • Number of events 2 • Subjects were followed for an average of 8 months for adverse event data.
|
|
General disorders
Headaches - Grade 2
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
General disorders
Hoarseness
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
General disorders
Mediastinal lymphadenopathy - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
General disorders
Myalgia
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
20.0%
2/10 • Number of events 2 • Subjects were followed for an average of 8 months for adverse event data.
|
|
General disorders
Neck Stiffness - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
General disorders
Pain - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
50.0%
5/10 • Number of events 5 • Subjects were followed for an average of 8 months for adverse event data.
|
|
General disorders
Pain - Grade 2
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
General disorders
Pain - Abdominal - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
General disorders
Pain-Back - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
30.0%
3/10 • Number of events 3 • Subjects were followed for an average of 8 months for adverse event data.
|
|
General disorders
Pain-Back - Grade 2
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
General disorders
Pain-Bone - Grade1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
General disorders
Pain - Chest (non cardiac) - Grade
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
30.0%
3/10 • Number of events 3 • Subjects were followed for an average of 8 months for adverse event data.
|
|
General disorders
Pain - Chest Wall - Grade 2
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
General disorders
Pain Extremity - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
40.0%
4/10 • Number of events 4 • Subjects were followed for an average of 8 months for adverse event data.
|
|
General disorders
Pain - Hip
|
25.0%
1/4 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
0.00%
0/10 • Subjects were followed for an average of 8 months for adverse event data.
|
|
General disorders
Pain - Incision site - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
30.0%
3/10 • Number of events 3 • Subjects were followed for an average of 8 months for adverse event data.
|
|
General disorders
Pain - Joints - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
General disorders
Pain - Neck - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
General disorders
Pain - Rib - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
General disorders
Pain - Rib - Grade 2
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
General disorders
Pain - Scalp - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
General disorders
Pain - Stomach - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
General disorders
Palpable cord in right arm - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
General disorders
Palpable sclerosed veins - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
General disorders
Polydipsia - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
General disorders
Nasal congestion - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
General disorders
Sore throat - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
40.0%
4/10 • Number of events 4 • Subjects were followed for an average of 8 months for adverse event data.
|
|
General disorders
Congestion - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Immune system disorders
Hypothyroidism - Grade 2
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Hepatobiliary disorders
Alkaline Phosphatase increased - Grade 2
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Hepatobiliary disorders
Alanine Aminotransferase (ALT) increased - Grade 2
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Metabolism and nutrition disorders
Acidosis - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Skin and subcutaneous tissue disorders
acne - Grade 2
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
General disorders
Activity change - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
20.0%
2/10 • Number of events 2 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
20.0%
2/10 • Number of events 2 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Hepatobiliary disorders
Alanine Aminotransferase (ALT) increased - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
20.0%
2/10 • Number of events 2 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Immune system disorders
Allergic Rhinitis - Grade 1
|
25.0%
1/4 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Immune system disorders
Alopecia - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
30.0%
3/10 • Number of events 3 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Blood and lymphatic system disorders
Anemia - Grade 2
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Blood and lymphatic system disorders
Anemia - Grade1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
20.0%
2/10 • Number of events 2 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Blood and lymphatic system disorders
Anemia - Grade 3
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Metabolism and nutrition disorders
Anorexia - Grade 1
|
25.0%
1/4 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
60.0%
6/10 • Number of events 6 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Psychiatric disorders
Anxiety - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
20.0%
2/10 • Number of events 2 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
30.0%
3/10 • Number of events 3 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Musculoskeletal and connective tissue disorders
Arthritis - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Hepatobiliary disorders
Aspartate Aminotransferase (AST) increased - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
20.0%
2/10 • Number of events 2 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Hepatobiliary disorders
Alkaline Phosphatase increased - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
20.0%
2/10 • Number of events 2 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Blood and lymphatic system disorders
Decreased Hemoglobin - Grade 3
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Blood and lymphatic system disorders
Hypercalcemia - Grade 1
|
25.0%
1/4 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
0.00%
0/10 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Blood and lymphatic system disorders
Hyperlipidemia - Grade 1
|
25.0%
1/4 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
0.00%
0/10 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Cardiac disorders
Bradycardia - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Cardiac disorders
Orthostatic - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Gastrointestinal disorders
Decreased Appetite - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Gastrointestinal disorders
Dental problem - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Gastrointestinal disorders
Diarrhea - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
60.0%
6/10 • Number of events 6 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Gastrointestinal disorders
Diarrhea -Grade 2
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Gastrointestinal disorders
Flatulence - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Gastrointestinal disorders
Dysgeusia - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
30.0%
3/10 • Number of events 3 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Vascular disorders
Gastroesophageal reflux disease - Grade 1
|
25.0%
1/4 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
20.0%
2/10 • Number of events 2 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Gastrointestinal disorders
Indigestion - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Gastrointestinal disorders
Loose Tooth - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Gastrointestinal disorders
Mucus discharge - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Gastrointestinal disorders
Nausea - Grade 1
|
25.0%
1/4 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
100.0%
10/10 • Number of events 10 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Gastrointestinal disorders
Nausea -Grade 2
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
20.0%
2/10 • Number of events 2 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Gastrointestinal disorders
Poor dentition - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Gastrointestinal disorders
Shakiness - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Gastrointestinal disorders
Vomiting - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
70.0%
7/10 • Number of events 7 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Gastrointestinal disorders
Activity change 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
20.0%
2/10 • Number of events 2 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Immune system disorders
Nasal congestion - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
20.0%
2/10 • Number of events 2 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Immune system disorders
Neutrophil count decreased - Grade 3
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
20.0%
2/10 • Number of events 2 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Immune system disorders
Platelet count decreased - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
20.0%
2/10 • Number of events 2 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Immune system disorders
Postnasal drip - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Immune system disorders
Sinus Pressure - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Immune system disorders
Upper respiratory Infection - Grade 2
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Infections and infestations
Lung Infection - Grade 3
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Infections and infestations
Sepsis - Grade 3
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Infections and infestations
Skin infection - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Injury, poisoning and procedural complications
Facial trauma - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Injury, poisoning and procedural complications
Incision wound injury - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
25.0%
1/4 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
20.0%
2/10 • Number of events 2 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Injury, poisoning and procedural complications
Infusion site reaction - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Injury, poisoning and procedural complications
Right shoulder injury - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Metabolism and nutrition disorders
Bloating - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Metabolism and nutrition disorders
Dehydration - Grade 2
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
20.0%
2/10 • Number of events 2 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Metabolism and nutrition disorders
Dehydration - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Metabolism and nutrition disorders
Hyperglycemia - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
20.0%
2/10 • Number of events 2 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Metabolism and nutrition disorders
Weight loss - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
30.0%
3/10 • Number of events 3 • Subjects were followed for an average of 8 months for adverse event data.
|
|
Musculoskeletal and connective tissue disorders
Brachial plexus impingement - Grade 1
|
0.00%
0/4 • Subjects were followed for an average of 8 months for adverse event data.
|
10.0%
1/10 • Number of events 1 • Subjects were followed for an average of 8 months for adverse event data.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place