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Trial Outcomes & Findings for Pembrolizumab Plus Chemotherapy in NSCLC With Targetable Genetic Alterations After Progression on Targeted Agents (NCT NCT03242915)

NCT ID: NCT03242915

Last Updated: 2025-05-30

Results Overview

The primary endpoint is Response Rate (RR) defined as the rate of complete and partial response. Complete Response (CR): Disappearance of all non-target lesions. All lymph nodes must be non-pathological in size (\<10mm short axis). Partial Response (PR): Persistence of one or more non-target lesion(s) but does not qualify for PD. Progressive Disease (PD): Unequivocal progression of existing non-target lesions. (Note: the appearance of one or more new lesions is also considered progression).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

33 participants

Primary outcome timeframe

5.5 years

Results posted on

2025-05-30

Participant Flow

Participant milestones

Participant milestones
Measure
EGFR+ NSCLC
Pembrolizumab 200 mg with carboplatin at AUC (area under the curve dosing) 5 and pemetrexed at 500 mg/m2 administered intravenously every 3 weeks Pembrolizumab: 200mg IV every 3 weeks Carboplatin: AUC 5 IV every 3 weeks Pemetrexed: 500 mg/m\^2 IV every 3 weeks
ALK+ NSCLC
Pembrolizumab 200 mg with carboplatin at AUC (area under the curve dosing) 5 and pemetrexed at 500 mg/m2 administered intravenously every 3 weeks Pembrolizumab: 200mg IV every 3 weeks Carboplatin: AUC 5 IV every 3 weeks Pemetrexed: 500 mg/m\^2 IV every 3 weeks
Overall Study
STARTED
26
7
Overall Study
COMPLETED
17
3
Overall Study
NOT COMPLETED
9
4

Reasons for withdrawal

Reasons for withdrawal
Measure
EGFR+ NSCLC
Pembrolizumab 200 mg with carboplatin at AUC (area under the curve dosing) 5 and pemetrexed at 500 mg/m2 administered intravenously every 3 weeks Pembrolizumab: 200mg IV every 3 weeks Carboplatin: AUC 5 IV every 3 weeks Pemetrexed: 500 mg/m\^2 IV every 3 weeks
ALK+ NSCLC
Pembrolizumab 200 mg with carboplatin at AUC (area under the curve dosing) 5 and pemetrexed at 500 mg/m2 administered intravenously every 3 weeks Pembrolizumab: 200mg IV every 3 weeks Carboplatin: AUC 5 IV every 3 weeks Pemetrexed: 500 mg/m\^2 IV every 3 weeks
Overall Study
Adverse Event
5
1
Overall Study
Withdrawal by Subject
0
2
Overall Study
Physician Decision
4
1

Baseline Characteristics

Pembrolizumab Plus Chemotherapy in NSCLC With Targetable Genetic Alterations After Progression on Targeted Agents

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
EGFR+ NSCLC
n=26 Participants
Pembrolizumab 200 mg with carboplatin at AUC (area under the curve dosing) 5 and pemetrexed at 500 mg/m2 administered intravenously every 3 weeks Pembrolizumab: 200mg IV every 3 weeks Carboplatin: AUC 5 IV every 3 weeks Pemetrexed: 500 mg/m\^2 IV every 3 weeks
ALK+ NSCLC
n=7 Participants
Pembrolizumab 200 mg with carboplatin at AUC (area under the curve dosing) 5 and pemetrexed at 500 mg/m2 administered intravenously every 3 weeks Pembrolizumab: 200mg IV every 3 weeks Carboplatin: AUC 5 IV every 3 weeks Pemetrexed: 500 mg/m\^2 IV every 3 weeks
Total
n=33 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Age, Categorical
Between 18 and 65 years
11 Participants
n=99 Participants
3 Participants
n=107 Participants
14 Participants
n=206 Participants
Age, Categorical
>=65 years
15 Participants
n=99 Participants
4 Participants
n=107 Participants
19 Participants
n=206 Participants
Sex: Female, Male
Female
17 Participants
n=99 Participants
4 Participants
n=107 Participants
21 Participants
n=206 Participants
Sex: Female, Male
Male
9 Participants
n=99 Participants
3 Participants
n=107 Participants
12 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants
n=99 Participants
1 Participants
n=107 Participants
4 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
21 Participants
n=99 Participants
6 Participants
n=107 Participants
27 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants
n=99 Participants
0 Participants
n=107 Participants
2 Participants
n=206 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Asian
2 Participants
n=99 Participants
0 Participants
n=107 Participants
2 Participants
n=206 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Black or African American
4 Participants
n=99 Participants
0 Participants
n=107 Participants
4 Participants
n=206 Participants
Race (NIH/OMB)
White
17 Participants
n=99 Participants
6 Participants
n=107 Participants
23 Participants
n=206 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants
n=99 Participants
1 Participants
n=107 Participants
4 Participants
n=206 Participants
Region of Enrollment
United States
26 participants
n=99 Participants
7 participants
n=107 Participants
33 participants
n=206 Participants

PRIMARY outcome

Timeframe: 5.5 years

The primary endpoint is Response Rate (RR) defined as the rate of complete and partial response. Complete Response (CR): Disappearance of all non-target lesions. All lymph nodes must be non-pathological in size (\<10mm short axis). Partial Response (PR): Persistence of one or more non-target lesion(s) but does not qualify for PD. Progressive Disease (PD): Unequivocal progression of existing non-target lesions. (Note: the appearance of one or more new lesions is also considered progression).

Outcome measures

Outcome measures
Measure
EGFR+ NSCLC
n=26 Participants
Pembrolizumab 200 mg with carboplatin at AUC (area under the curve dosing) 5 and pemetrexed at 500 mg/m2 administered intravenously every 3 weeks Pembrolizumab: 200mg IV every 3 weeks Carboplatin: AUC 5 IV every 3 weeks Pemetrexed: 500 mg/m\^2 IV every 3 weeks
ALK+ NSCLC
n=7 Participants
Pembrolizumab 200 mg with carboplatin at AUC (area under the curve dosing) 5 and pemetrexed at 500 mg/m2 administered intravenously every 3 weeks Pembrolizumab: 200mg IV every 3 weeks Carboplatin: AUC 5 IV every 3 weeks Pemetrexed: 500 mg/m\^2 IV every 3 weeks
The Percentage of Patients That Respond to Treatment
46 percentage of patients
Interval 27.0 to 67.0
29 percentage of patients
Interval 4.0 to 71.0

SECONDARY outcome

Timeframe: 5.5 years

PFS is defined as the duration of time from registration to time of progression. Progressive Disease (PD): Unequivocal progression of existing non-target lesions. (Note: the appearance of one or more new lesions is also considered progression).

Outcome measures

Outcome measures
Measure
EGFR+ NSCLC
n=26 Participants
Pembrolizumab 200 mg with carboplatin at AUC (area under the curve dosing) 5 and pemetrexed at 500 mg/m2 administered intravenously every 3 weeks Pembrolizumab: 200mg IV every 3 weeks Carboplatin: AUC 5 IV every 3 weeks Pemetrexed: 500 mg/m\^2 IV every 3 weeks
ALK+ NSCLC
n=7 Participants
Pembrolizumab 200 mg with carboplatin at AUC (area under the curve dosing) 5 and pemetrexed at 500 mg/m2 administered intravenously every 3 weeks Pembrolizumab: 200mg IV every 3 weeks Carboplatin: AUC 5 IV every 3 weeks Pemetrexed: 500 mg/m\^2 IV every 3 weeks
Progression Free Survival (PFS) Time
8.3 Months
Interval 7.2 to 16.5
2.9 Months
Interval 1.1 to
Not evaluable as there were not a sufficient number of events for us to estimate those values

SECONDARY outcome

Timeframe: 5.5 years

Overall survival is defined as the time from registration to time of death. If the patient is lost to follow-up, survival will be censored on the last date the patient was known to be alive.

Outcome measures

Outcome measures
Measure
EGFR+ NSCLC
n=26 Participants
Pembrolizumab 200 mg with carboplatin at AUC (area under the curve dosing) 5 and pemetrexed at 500 mg/m2 administered intravenously every 3 weeks Pembrolizumab: 200mg IV every 3 weeks Carboplatin: AUC 5 IV every 3 weeks Pemetrexed: 500 mg/m\^2 IV every 3 weeks
ALK+ NSCLC
n=7 Participants
Pembrolizumab 200 mg with carboplatin at AUC (area under the curve dosing) 5 and pemetrexed at 500 mg/m2 administered intravenously every 3 weeks Pembrolizumab: 200mg IV every 3 weeks Carboplatin: AUC 5 IV every 3 weeks Pemetrexed: 500 mg/m\^2 IV every 3 weeks
Overall Survival (OS) Time
22.2 Months
Interval 20.6 to
Not evaluable as there were not a sufficient number of events for us to estimate those values
2.9 Months
Interval 1.1 to
Not evaluable as there were not a sufficient number of events for us to estimate those values

Adverse Events

EGFR+ NSCLC

Serious events: 10 serious events
Other events: 26 other events
Deaths: 24 deaths

ALK+ NSCLC

Serious events: 7 serious events
Other events: 7 other events
Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure
EGFR+ NSCLC
n=26 participants at risk
Pembrolizumab 200 mg with carboplatin at AUC (area under the curve dosing) 5 and pemetrexed at 500 mg/m2 administered intravenously every 3 weeks Pembrolizumab: 200mg IV every 3 weeks Carboplatin: AUC 5 IV every 3 weeks Pemetrexed: 500 mg/m\^2 IV every 3 weeks
ALK+ NSCLC
n=7 participants at risk
Pembrolizumab 200 mg with carboplatin at AUC (area under the curve dosing) 5 and pemetrexed at 500 mg/m2 administered intravenously every 3 weeks Pembrolizumab: 200mg IV every 3 weeks Carboplatin: AUC 5 IV every 3 weeks Pemetrexed: 500 mg/m\^2 IV every 3 weeks
Gastrointestinal disorders
Abdominal pain
0.00%
0/26 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
14.3%
1/7 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Gastrointestinal disorders
Acidosis
0.00%
0/26 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
14.3%
1/7 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Renal and urinary disorders
Acute kidney injury
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
28.6%
2/7 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Investigations
Alanine aminotransferase increased
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Investigations
Aspartate aminotransferase increased
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
General disorders
Back pain
0.00%
0/26 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
14.3%
1/7 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Cardiac disorders
Cardiac arrest
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Gastrointestinal disorders
Colonic obstruction
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Respiratory, thoracic and mediastinal disorders
Dyspnea
0.00%
0/26 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
14.3%
1/7 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Investigations
Febrile neutropenia
0.00%
0/26 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
14.3%
1/7 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Progressive Disease
0.00%
0/26 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
28.6%
2/7 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Metabolism and nutrition disorders
Hyperglycemia
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Metabolism and nutrition disorders
Hypoglycemia
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.00%
0/26 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
14.3%
1/7 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Infections and infestations
Infections and infestations - Other, specify
0.00%
0/26 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
14.3%
1/7 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Infections and infestations
Lung infection
7.7%
2/26 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
14.3%
1/7 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Cardiac disorders
Pericardial tamponade
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Investigations
Platelet count decreased
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Infections and infestations
Pleural effusion
0.00%
0/26 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
42.9%
3/7 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Respiratory, thoracic and mediastinal disorders
Respiratory failure
0.00%
0/26 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
14.3%
1/7 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Infections and infestations
Sepsis
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
14.3%
1/7 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
General disorders
Stroke
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Blood and lymphatic system disorders
Thromboembolic event
7.7%
2/26 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Infections and infestations
Upper respiratory infection
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.

Other adverse events

Other adverse events
Measure
EGFR+ NSCLC
n=26 participants at risk
Pembrolizumab 200 mg with carboplatin at AUC (area under the curve dosing) 5 and pemetrexed at 500 mg/m2 administered intravenously every 3 weeks Pembrolizumab: 200mg IV every 3 weeks Carboplatin: AUC 5 IV every 3 weeks Pemetrexed: 500 mg/m\^2 IV every 3 weeks
ALK+ NSCLC
n=7 participants at risk
Pembrolizumab 200 mg with carboplatin at AUC (area under the curve dosing) 5 and pemetrexed at 500 mg/m2 administered intravenously every 3 weeks Pembrolizumab: 200mg IV every 3 weeks Carboplatin: AUC 5 IV every 3 weeks Pemetrexed: 500 mg/m\^2 IV every 3 weeks
Gastrointestinal disorders
Abdominal pain
7.7%
2/26 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
14.3%
1/7 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Psychiatric disorders
Agitation
0.00%
0/26 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
14.3%
1/7 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Investigations
Alanine aminotransferase increased
42.3%
11/26 • Number of events 22 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
14.3%
1/7 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Investigations
Alkaline phosphatase increased
26.9%
7/26 • Number of events 10 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
28.6%
2/7 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Injury, poisoning and procedural complications
Allergic reaction
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
General disorders
Alopecia
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
General disorders
Amnesia
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Investigations
Anemia
80.8%
21/26 • Number of events 46 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
71.4%
5/7 • Number of events 18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Metabolism and nutrition disorders
Anorexia
26.9%
7/26 • Number of events 9 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
28.6%
2/7 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Psychiatric disorders
Anxiety
7.7%
2/26 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
14.3%
1/7 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
General disorders
Arthralgia
11.5%
3/26 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
General disorders
Arthritis
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Investigations
Aspartate aminotransferase increased
30.8%
8/26 • Number of events 14 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
28.6%
2/7 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Cardiac disorders
Atrial fibrillation
7.7%
2/26 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
General disorders
Back pain
11.5%
3/26 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Renal and urinary disorders
Blood bilirubin increased
7.7%
2/26 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
14.3%
1/7 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Eye disorders
Blurred vision
11.5%
3/26 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
General disorders
Bone pain
15.4%
4/26 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
14.3%
1/7 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Skin and subcutaneous tissue disorders
Bullous dermatitis
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
General disorders
Chills
7.7%
2/26 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Blood and lymphatic system disorders
Cholesterol high
0.00%
0/26 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
14.3%
1/7 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Psychiatric disorders
Confusion
7.7%
2/26 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
14.3%
1/7 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Eye disorders
Conjunctivitis
7.7%
2/26 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Gastrointestinal disorders
Constipation
50.0%
13/26 • Number of events 18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
14.3%
1/7 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Respiratory, thoracic and mediastinal disorders
Cough
26.9%
7/26 • Number of events 8 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
14.3%
1/7 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Investigations
Creatinine increased
19.2%
5/26 • Number of events 8 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
28.6%
2/7 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Metabolism and nutrition disorders
Dehydration
15.4%
4/26 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
14.3%
1/7 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Psychiatric disorders
Depression
11.5%
3/26 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Gastrointestinal disorders
Diarrhea
19.2%
5/26 • Number of events 6 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
42.9%
3/7 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
General disorders
Dizziness
19.2%
5/26 • Number of events 9 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
14.3%
1/7 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Skin and subcutaneous tissue disorders
Dry skin
7.7%
2/26 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Metabolism and nutrition disorders
Dysgeusia
7.7%
2/26 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Gastrointestinal disorders
Dyspepsia
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
General disorders
Dysphagia
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Respiratory, thoracic and mediastinal disorders
Dyspnea
30.8%
8/26 • Number of events 9 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
14.3%
1/7 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
General disorders
Edema face
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
General disorders
Edema limbs
23.1%
6/26 • Number of events 7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
28.6%
2/7 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Endocrine disorders
Endocrine disorders - Other, specify
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Blood and lymphatic system disorders
Epistaxis
7.7%
2/26 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Gastrointestinal disorders
Esophagitis
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Ear and labyrinth disorders
Eye disorders - Other, specify
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
General disorders
Facial pain
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
General disorders
Fall
7.7%
2/26 • Number of events 7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
General disorders
Fatigue
65.4%
17/26 • Number of events 24 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
71.4%
5/7 • Number of events 10 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
General disorders
Fever
15.4%
4/26 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
14.3%
1/7 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
General disorders
Flu like symptoms
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
General disorders
Flushing
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
General disorders
Gait disturbance
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
General disorders
General disorders and administration site conditions - Other, specify
0.00%
0/26 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
14.3%
1/7 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
3.8%
1/26 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
28.6%
2/7 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Nervous system disorders
Headache
15.4%
4/26 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Ear and labyrinth disorders
Hearing impaired
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Renal and urinary disorders
Hematuria
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Gastrointestinal disorders
Hemorrhoids
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Respiratory, thoracic and mediastinal disorders
Hoarseness
3.8%
1/26 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Vascular disorders
Hot flashes
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
14.3%
1/7 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Metabolism and nutrition disorders
Hypercalcemia
0.00%
0/26 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
14.3%
1/7 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Metabolism and nutrition disorders
Hyperglycemia
26.9%
7/26 • Number of events 22 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
28.6%
2/7 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Metabolism and nutrition disorders
Hyperkalemia
15.4%
4/26 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
14.3%
1/7 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Metabolism and nutrition disorders
Hypernatremia
0.00%
0/26 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
14.3%
1/7 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Vascular disorders
Hypertension
19.2%
5/26 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
14.3%
1/7 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Endocrine disorders
Hyperthyroidism
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Metabolism and nutrition disorders
Hypoalbuminemia
23.1%
6/26 • Number of events 9 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
57.1%
4/7 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Metabolism and nutrition disorders
Hypocalcemia
26.9%
7/26 • Number of events 8 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
28.6%
2/7 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Metabolism and nutrition disorders
Hypoglycemia
23.1%
6/26 • Number of events 10 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Metabolism and nutrition disorders
Hypokalemia
0.00%
0/26 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
28.6%
2/7 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Metabolism and nutrition disorders
Hypomagnesemia
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Metabolism and nutrition disorders
Hyponatremia
53.8%
14/26 • Number of events 18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
42.9%
3/7 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Metabolism and nutrition disorders
Hypophosphatemia
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Vascular disorders
Hypotension
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Endocrine disorders
Hypothyroidism
11.5%
3/26 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Respiratory, thoracic and mediastinal disorders
Hypoxia
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
28.6%
2/7 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
General disorders
Infusion related reaction
3.8%
1/26 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Psychiatric disorders
Insomnia
7.7%
2/26 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
14.3%
1/7 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Investigations
Investigations - Other, specify
0.00%
0/26 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
14.3%
1/7 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
General disorders
Irritability
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Infections and infestations
Lung infection
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Investigations
Lymphocyte count decreased
38.5%
10/26 • Number of events 36 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
71.4%
5/7 • Number of events 11 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
General disorders
Malaise
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Ear and labyrinth disorders
Middle ear inflammation
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Infections and infestations
Mucosal infection
3.8%
1/26 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Gastrointestinal disorders
Mucositis oral
7.7%
2/26 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Musculoskeletal and connective tissue disorders
Myalgia
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Respiratory, thoracic and mediastinal disorders
Nasal congestion
7.7%
2/26 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
14.3%
1/7 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Gastrointestinal disorders
Nausea
57.7%
15/26 • Number of events 20 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
71.4%
5/7 • Number of events 7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Musculoskeletal and connective tissue disorders
Neck pain
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Nervous system disorders
Nervous system disorders - Other, specify
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Investigations
Neutrophil count decreased
34.6%
9/26 • Number of events 21 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
14.3%
1/7 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
General disorders
Non-cardiac chest pain
11.5%
3/26 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
28.6%
2/7 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
General disorders
Pain
30.8%
8/26 • Number of events 11 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Musculoskeletal and connective tissue disorders
Pain in extremity
7.7%
2/26 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Cardiac disorders
Palpitations
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Nervous system disorders
Paresthesia
7.7%
2/26 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Investigations
Platelet count decreased
23.1%
6/26 • Number of events 10 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
28.6%
2/7 • Number of events 7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
7.7%
2/26 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Respiratory, thoracic and mediastinal disorders
Pneumonitis
3.8%
1/26 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Nervous system disorders
Presyncope
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Skin and subcutaneous tissue disorders
Pruritus
23.1%
6/26 • Number of events 6 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
14.3%
1/7 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Skin and subcutaneous tissue disorders
Rash acneiform
15.4%
4/26 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
14.3%
1/7 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Skin and subcutaneous tissue disorders
Rash maculo-papular
19.2%
5/26 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Eye disorders
Retinal detachment
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Cardiac disorders
Sinus bradycardia
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Nervous system disorders
Sinus pain
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Cardiac disorders
Sinus tachycardia
15.4%
4/26 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
57.1%
4/7 • Number of events 6 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Infections and infestations
Sinusitis
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
7.7%
2/26 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Skin and subcutaneous tissue disorders
Skin ulceration
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
14.3%
1/7 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Infections and infestations
Soft tissue infection
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Nervous system disorders
Somnolence
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Respiratory, thoracic and mediastinal disorders
Sore throat
11.5%
3/26 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Vascular disorders
Thromboembolic event
0.00%
0/26 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
42.9%
3/7 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Infections and infestations
Upper respiratory infection
11.5%
3/26 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Renal and urinary disorders
Urinary frequency
7.7%
2/26 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Renal and urinary disorders
Urinary incontinence
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Infections and infestations
Urinary tract infection
11.5%
3/26 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Reproductive system and breast disorders
Vaginal discharge
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Gastrointestinal disorders
Vomiting
19.2%
5/26 • Number of events 7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
57.1%
4/7 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Eye disorders
Watering eyes
11.5%
3/26 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Investigations
Weight gain
3.8%
1/26 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Investigations
Weight loss
19.2%
5/26 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
28.6%
2/7 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Respiratory, thoracic and mediastinal disorders
Wheezing
7.7%
2/26 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
0.00%
0/7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
Investigations
White blood cell decreased
57.7%
15/26 • Number of events 44 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.
14.3%
1/7 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Up to 2 years for adverse events and serious adverse events. 5.5 years for survival.

Additional Information

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Results disclosure agreements

  • Principal investigator is a sponsor employee * Participating Sites agree not to publish or publicly present the Study Data or Study Results until Michigan or Michigan's Principal Investigator have first Published the Study Data or Study Results * All Study Data and Results generated by the Participating Site will be owned by Participating Site * Sponsors have the right to review and comment on any Public Presentation as defined by the contract * Other limitations outline within the contract
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