Trial Outcomes & Findings for Selumetinib in Patients Receiving Pemetrexed and Platinum-based Chemotherapy in Advanced or Metastatic KRAS Wildtype or Unknown Non-Squamous NSCLC (NCT NCT02337530)
NCT ID: NCT02337530
Last Updated: 2024-03-21
Results Overview
Defined as percentage of participants with objective response over all participants randomized. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
62 participants
Primary outcome timeframe
2 years and 5 months.
Results posted on
2024-03-21
Participant Flow
Subjects were recruited between February 2015 and May 2017 from cancer centres in Canada.
Participant milestones
| Measure |
Intermittent Oral Selumatinib With Pemetrexed and Platinum
Selumetinib: 75mg/ bid PO given on days 2-19 Pemetrexed: 500mg/m\^2 \& Cisplatin or Carboplatin\*: AUC6: 75mg/m\^2 given on day 1 Schedule = q 21 days
\*Must be specified at time of randomization. Patients who start on treatment with cisplatin may switch to carboplatin only after discussion with CCTG
Selumetinib
Pemetrexed
Cisplatin
Carboplatin
|
Continuous Oral Selumatinib With Pemetrexed and Platinum
Selumetinib: 75mg/ bid PO given on days 1-21 (continuous) Pemetrexed: 500mg/m\^2 \& Cisplatin\*: 75mg/m\^2 or carboplatin AUC 6 given on day 1 Schedule = q 21 days
\*\*Must be specified at time of randomization. Patients who start on treatment with cisplatin may switch to carboplatin only after discussion with CCTG
Selumetinib
Pemetrexed
Cisplatin
Carboplatin
|
Pemetrexed and Platinum Alone
Selumetinib: NOT GIVEN Pemetrexed: 500mg/m\^2 \& Cisplatin\*: 75mg/m\^2 or carboplatin AUC6 given on day 1 Schedule = q 21 days
\*Must be specified at time of randomization. Patients who start on treatment with cisplatin may switch to carboplatin only after discussion with CCTG
Pemetrexed
Cisplatin
Carboplatin
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
21
|
21
|
|
Overall Study
COMPLETED
|
20
|
21
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Selumetinib in Patients Receiving Pemetrexed and Platinum-based Chemotherapy in Advanced or Metastatic KRAS Wildtype or Unknown Non-Squamous NSCLC
Baseline characteristics by cohort
| Measure |
Intermittent Oral Selumatinib With Pemetrexed and Platinum
n=20 Participants
Selumetinib: 75mg/ bid PO given on days 2-19 Pemetrexed: 500mg/m\^2 \& Cisplatin or Carboplatin\*: AUC6: 75mg/m\^2 given on day 1 Schedule = q 21 days
\*Must be specified at time of randomization. Patients who start on treatment with cisplatin may switch to carboplatin only after discussion with CCTG
Selumetinib
Pemetrexed
Cisplatin
Carboplatin
|
Continuous Oral Selumatinib With Pemetrexed and Platinum
n=21 Participants
Selumetinib: 75mg/ bid PO given on days 1-21 (continuous) Pemetrexed: 500mg/m\^2 \& Cisplatin\*: 75mg/m\^2 or carboplatin AUC 6 given on day 1 Schedule = q 21 days
\*\*Must be specified at time of randomization. Patients who start on treatment with cisplatin may switch to carboplatin only after discussion with CCTG
Selumetinib
Pemetrexed
Cisplatin
Carboplatin
|
Pemetrexed and Platinum Alone
n=21 Participants
Selumetinib: NOT GIVEN Pemetrexed: 500mg/m\^2 \& Cisplatin\*: 75mg/m\^2 or carboplatin AUC6 given on day 1 Schedule = q 21 days
\*Must be specified at time of randomization. Patients who start on treatment with cisplatin may switch to carboplatin only after discussion with CCTG
Pemetrexed
Cisplatin
Carboplatin
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Age, Continuous
|
68 years
n=5 Participants
|
66 years
n=7 Participants
|
65 years
n=5 Participants
|
66 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
20 participants
n=5 Participants
|
21 participants
n=7 Participants
|
21 participants
n=5 Participants
|
62 participants
n=4 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
0
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
1
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 2 years and 5 months.Defined as percentage of participants with objective response over all participants randomized. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.
Outcome measures
| Measure |
Intermittent Oral Selumatinib With Pemetrexed and Platinum
n=20 Participants
Selumetinib: 75mg/ bid PO given on days 2-19 Pemetrexed: 500mg/m\^2 \& Cisplatin or Carboplatin\*: AUC6: 75mg/m\^2 given on day 1 Schedule = q 21 days
\*Must be specified at time of randomization. Patients who start on treatment with cisplatin may switch to carboplatin only after discussion with CCTG
Selumetinib
Pemetrexed
Cisplatin
Carboplatin
|
Continuous Oral Selumatinib With Pemetrexed and Platinum
n=21 Participants
Selumetinib: 75mg/ bid PO given on days 1-21 (continuous) Pemetrexed: 500mg/m\^2 \& Cisplatin\*: 75mg/m\^2 or carboplatin AUC 6 given on day 1 Schedule = q 21 days
\*\*Must be specified at time of randomization. Patients who start on treatment with cisplatin may switch to carboplatin only after discussion with CCTG
Selumetinib
Pemetrexed
Cisplatin
Carboplatin
|
Pemetrexed and Platinum Alone
n=21 Participants
Selumetinib: NOT GIVEN Pemetrexed: 500mg/m\^2 \& Cisplatin\*: 75mg/m\^2 or carboplatin AUC6 given on day 1 Schedule = q 21 days
\*Must be specified at time of randomization. Patients who start on treatment with cisplatin may switch to carboplatin only after discussion with CCTG
Pemetrexed
Cisplatin
Carboplatin
|
|---|---|---|---|
|
Objective Response Rate
Responded
|
6 Participants
|
14 Participants
|
5 Participants
|
|
Objective Response Rate
Not Responded
|
14 Participants
|
7 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: 2 years 5 monthsDefined as the time from randomization to the first objective documentation of disease progression, defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions, or death due to any cause with patients who had not progressed or died at the time of final analysis censored on the date of the last tumour assessment.
Outcome measures
| Measure |
Intermittent Oral Selumatinib With Pemetrexed and Platinum
n=20 Participants
Selumetinib: 75mg/ bid PO given on days 2-19 Pemetrexed: 500mg/m\^2 \& Cisplatin or Carboplatin\*: AUC6: 75mg/m\^2 given on day 1 Schedule = q 21 days
\*Must be specified at time of randomization. Patients who start on treatment with cisplatin may switch to carboplatin only after discussion with CCTG
Selumetinib
Pemetrexed
Cisplatin
Carboplatin
|
Continuous Oral Selumatinib With Pemetrexed and Platinum
n=21 Participants
Selumetinib: 75mg/ bid PO given on days 1-21 (continuous) Pemetrexed: 500mg/m\^2 \& Cisplatin\*: 75mg/m\^2 or carboplatin AUC 6 given on day 1 Schedule = q 21 days
\*\*Must be specified at time of randomization. Patients who start on treatment with cisplatin may switch to carboplatin only after discussion with CCTG
Selumetinib
Pemetrexed
Cisplatin
Carboplatin
|
Pemetrexed and Platinum Alone
n=21 Participants
Selumetinib: NOT GIVEN Pemetrexed: 500mg/m\^2 \& Cisplatin\*: 75mg/m\^2 or carboplatin AUC6 given on day 1 Schedule = q 21 days
\*Must be specified at time of randomization. Patients who start on treatment with cisplatin may switch to carboplatin only after discussion with CCTG
Pemetrexed
Cisplatin
Carboplatin
|
|---|---|---|---|
|
Progression Free Survival
|
7.2 months
Interval 4.0 to 8.6
|
6.9 months
Interval 4.6 to 8.6
|
4.0 months
Interval 1.4 to 6.8
|
Adverse Events
Intermittent Oral Selumatinib With Pemetrexed and Platinum
Serious events: 14 serious events
Other events: 20 other events
Deaths: 13 deaths
Continuous Oral Selumatinib With Pemetrexed and Platinum
Serious events: 14 serious events
Other events: 21 other events
Deaths: 15 deaths
Pemetrexed and Platinum Alone
Serious events: 9 serious events
Other events: 21 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Intermittent Oral Selumatinib With Pemetrexed and Platinum
n=20 participants at risk
Selumetinib: 75mg/ bid PO given on days 2-19 Pemetrexed: 500mg/m\^2 \& Cisplatin or Carboplatin\*: AUC6: 75mg/m\^2 given on day 1 Schedule = q 21 days
\*Must be specified at time of randomization. Patients who start on treatment with cisplatin may switch to carboplatin only after discussion with CCTG
Selumetinib
Pemetrexed
Cisplatin
Carboplatin
|
Continuous Oral Selumatinib With Pemetrexed and Platinum
n=21 participants at risk
Selumetinib: 75mg/ bid PO given on days 1-21 (continuous) Pemetrexed: 500mg/m\^2 \& Cisplatin\*: 75mg/m\^2 or carboplatin AUC 6 given on day 1 Schedule = q 21 days
\*\*Must be specified at time of randomization. Patients who start on treatment with cisplatin may switch to carboplatin only after discussion with CCTG
Selumetinib
Pemetrexed
Cisplatin
Carboplatin
|
Pemetrexed and Platinum Alone
n=21 participants at risk
Selumetinib: NOT GIVEN Pemetrexed: 500mg/m\^2 \& Cisplatin\*: 75mg/m\^2 or carboplatin AUC6 given on day 1 Schedule = q 21 days
\*Must be specified at time of randomization. Patients who start on treatment with cisplatin may switch to carboplatin only after discussion with CCTG
Pemetrexed
Cisplatin
Carboplatin
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/20 • 3 years
|
4.8%
1/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/20 • 3 years
|
0.00%
0/21 • 3 years
|
4.8%
1/21 • 3 years
|
|
Cardiac disorders
Acute coronary syndrome
|
5.0%
1/20 • 3 years
|
0.00%
0/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Cardiac disorders
Atrial fibrillation
|
5.0%
1/20 • 3 years
|
4.8%
1/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/20 • 3 years
|
0.00%
0/21 • 3 years
|
4.8%
1/21 • 3 years
|
|
Eye disorders
Other eye disorders
|
5.0%
1/20 • 3 years
|
0.00%
0/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Gastrointestinal disorders
Colonic perforation
|
0.00%
0/20 • 3 years
|
4.8%
1/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/20 • 3 years
|
9.5%
2/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
5.0%
1/20 • 3 years
|
0.00%
0/21 • 3 years
|
4.8%
1/21 • 3 years
|
|
Gastrointestinal disorders
Duodenal hemorrhage
|
5.0%
1/20 • 3 years
|
0.00%
0/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Gastrointestinal disorders
Enterocolitis
|
5.0%
1/20 • 3 years
|
0.00%
0/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
5.0%
1/20 • 3 years
|
14.3%
3/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
1/20 • 3 years
|
14.3%
3/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
General disorders
Edema limbs
|
0.00%
0/20 • 3 years
|
4.8%
1/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
General disorders
Fatigue
|
5.0%
1/20 • 3 years
|
4.8%
1/21 • 3 years
|
9.5%
2/21 • 3 years
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/20 • 3 years
|
0.00%
0/21 • 3 years
|
4.8%
1/21 • 3 years
|
|
Infections and infestations
Enterocolitis infectious
|
5.0%
1/20 • 3 years
|
0.00%
0/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Infections and infestations
Lung infection
|
10.0%
2/20 • 3 years
|
9.5%
2/21 • 3 years
|
9.5%
2/21 • 3 years
|
|
Infections and infestations
Pleural infection
|
5.0%
1/20 • 3 years
|
0.00%
0/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Infections and infestations
Sepsis
|
10.0%
2/20 • 3 years
|
4.8%
1/21 • 3 years
|
4.8%
1/21 • 3 years
|
|
Injury, poisoning and procedural complications
Fall
|
5.0%
1/20 • 3 years
|
0.00%
0/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/20 • 3 years
|
4.8%
1/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
5.0%
1/20 • 3 years
|
19.0%
4/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.0%
1/20 • 3 years
|
0.00%
0/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/20 • 3 years
|
4.8%
1/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/20 • 3 years
|
4.8%
1/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
0.00%
0/20 • 3 years
|
0.00%
0/21 • 3 years
|
4.8%
1/21 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.0%
1/20 • 3 years
|
0.00%
0/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Other neoplasms benign, malignant and unspecified
|
10.0%
2/20 • 3 years
|
4.8%
1/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Nervous system disorders
Depressed level of consciousness
|
5.0%
1/20 • 3 years
|
0.00%
0/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Nervous system disorders
Leukoencephalopathy
|
5.0%
1/20 • 3 years
|
0.00%
0/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Nervous system disorders
Seizure
|
0.00%
0/20 • 3 years
|
4.8%
1/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Nervous system disorders
Stroke
|
5.0%
1/20 • 3 years
|
0.00%
0/21 • 3 years
|
4.8%
1/21 • 3 years
|
|
Nervous system disorders
Syncope
|
0.00%
0/20 • 3 years
|
0.00%
0/21 • 3 years
|
4.8%
1/21 • 3 years
|
|
Psychiatric disorders
Delusions
|
0.00%
0/20 • 3 years
|
0.00%
0/21 • 3 years
|
4.8%
1/21 • 3 years
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/20 • 3 years
|
0.00%
0/21 • 3 years
|
4.8%
1/21 • 3 years
|
|
Renal and urinary disorders
Acute kidney injury
|
5.0%
1/20 • 3 years
|
0.00%
0/21 • 3 years
|
4.8%
1/21 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/20 • 3 years
|
0.00%
0/21 • 3 years
|
4.8%
1/21 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/20 • 3 years
|
4.8%
1/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
5.0%
1/20 • 3 years
|
0.00%
0/21 • 3 years
|
4.8%
1/21 • 3 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/20 • 3 years
|
9.5%
2/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Vascular disorders
Thromboembolic event
|
30.0%
6/20 • 3 years
|
4.8%
1/21 • 3 years
|
4.8%
1/21 • 3 years
|
|
Vascular disorders
Vasculitis
|
0.00%
0/20 • 3 years
|
4.8%
1/21 • 3 years
|
0.00%
0/21 • 3 years
|
Other adverse events
| Measure |
Intermittent Oral Selumatinib With Pemetrexed and Platinum
n=20 participants at risk
Selumetinib: 75mg/ bid PO given on days 2-19 Pemetrexed: 500mg/m\^2 \& Cisplatin or Carboplatin\*: AUC6: 75mg/m\^2 given on day 1 Schedule = q 21 days
\*Must be specified at time of randomization. Patients who start on treatment with cisplatin may switch to carboplatin only after discussion with CCTG
Selumetinib
Pemetrexed
Cisplatin
Carboplatin
|
Continuous Oral Selumatinib With Pemetrexed and Platinum
n=21 participants at risk
Selumetinib: 75mg/ bid PO given on days 1-21 (continuous) Pemetrexed: 500mg/m\^2 \& Cisplatin\*: 75mg/m\^2 or carboplatin AUC 6 given on day 1 Schedule = q 21 days
\*\*Must be specified at time of randomization. Patients who start on treatment with cisplatin may switch to carboplatin only after discussion with CCTG
Selumetinib
Pemetrexed
Cisplatin
Carboplatin
|
Pemetrexed and Platinum Alone
n=21 participants at risk
Selumetinib: NOT GIVEN Pemetrexed: 500mg/m\^2 \& Cisplatin\*: 75mg/m\^2 or carboplatin AUC6 given on day 1 Schedule = q 21 days
\*Must be specified at time of randomization. Patients who start on treatment with cisplatin may switch to carboplatin only after discussion with CCTG
Pemetrexed
Cisplatin
Carboplatin
|
|---|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
5.0%
1/20 • 3 years
|
0.00%
0/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Cardiac disorders
Atrial fibrillation
|
10.0%
2/20 • 3 years
|
9.5%
2/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/20 • 3 years
|
9.5%
2/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Ear and labyrinth disorders
Hearing impaired
|
5.0%
1/20 • 3 years
|
0.00%
0/21 • 3 years
|
19.0%
4/21 • 3 years
|
|
Ear and labyrinth disorders
Tinnitus
|
10.0%
2/20 • 3 years
|
19.0%
4/21 • 3 years
|
14.3%
3/21 • 3 years
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/20 • 3 years
|
14.3%
3/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Eye disorders
Blurred vision
|
15.0%
3/20 • 3 years
|
9.5%
2/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Eye disorders
Cataract
|
5.0%
1/20 • 3 years
|
0.00%
0/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Eye disorders
Dry eye
|
10.0%
2/20 • 3 years
|
4.8%
1/21 • 3 years
|
4.8%
1/21 • 3 years
|
|
Eye disorders
Watering eyes
|
20.0%
4/20 • 3 years
|
14.3%
3/21 • 3 years
|
28.6%
6/21 • 3 years
|
|
Eye disorders
Other eye disorders
|
10.0%
2/20 • 3 years
|
4.8%
1/21 • 3 years
|
4.8%
1/21 • 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
4/20 • 3 years
|
33.3%
7/21 • 3 years
|
14.3%
3/21 • 3 years
|
|
Gastrointestinal disorders
Bloating
|
20.0%
4/20 • 3 years
|
0.00%
0/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Gastrointestinal disorders
Colonic hemorrhage
|
5.0%
1/20 • 3 years
|
0.00%
0/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Gastrointestinal disorders
Constipation
|
60.0%
12/20 • 3 years
|
71.4%
15/21 • 3 years
|
85.7%
18/21 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
55.0%
11/20 • 3 years
|
61.9%
13/21 • 3 years
|
42.9%
9/21 • 3 years
|
|
Gastrointestinal disorders
Dry mouth
|
20.0%
4/20 • 3 years
|
9.5%
2/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Gastrointestinal disorders
Duodenal ulcer
|
5.0%
1/20 • 3 years
|
0.00%
0/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Gastrointestinal disorders
Dyspepsia
|
25.0%
5/20 • 3 years
|
23.8%
5/21 • 3 years
|
14.3%
3/21 • 3 years
|
|
Gastrointestinal disorders
Esophagitis
|
5.0%
1/20 • 3 years
|
0.00%
0/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
10.0%
2/20 • 3 years
|
19.0%
4/21 • 3 years
|
9.5%
2/21 • 3 years
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
5.0%
1/20 • 3 years
|
0.00%
0/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
15.0%
3/20 • 3 years
|
4.8%
1/21 • 3 years
|
9.5%
2/21 • 3 years
|
|
Gastrointestinal disorders
Lip pain
|
5.0%
1/20 • 3 years
|
0.00%
0/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Gastrointestinal disorders
Mucositis oral
|
15.0%
3/20 • 3 years
|
42.9%
9/21 • 3 years
|
28.6%
6/21 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
70.0%
14/20 • 3 years
|
76.2%
16/21 • 3 years
|
81.0%
17/21 • 3 years
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.00%
0/20 • 3 years
|
9.5%
2/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Gastrointestinal disorders
Oral pain
|
10.0%
2/20 • 3 years
|
4.8%
1/21 • 3 years
|
4.8%
1/21 • 3 years
|
|
Gastrointestinal disorders
Rectal pain
|
5.0%
1/20 • 3 years
|
0.00%
0/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Gastrointestinal disorders
Stomach pain
|
5.0%
1/20 • 3 years
|
9.5%
2/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
60.0%
12/20 • 3 years
|
76.2%
16/21 • 3 years
|
61.9%
13/21 • 3 years
|
|
Gastrointestinal disorders
Other gastrointestinal disorders
|
5.0%
1/20 • 3 years
|
9.5%
2/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
General disorders
Chills
|
0.00%
0/20 • 3 years
|
9.5%
2/21 • 3 years
|
4.8%
1/21 • 3 years
|
|
General disorders
Edema face
|
20.0%
4/20 • 3 years
|
23.8%
5/21 • 3 years
|
19.0%
4/21 • 3 years
|
|
General disorders
Edema limbs
|
55.0%
11/20 • 3 years
|
76.2%
16/21 • 3 years
|
52.4%
11/21 • 3 years
|
|
General disorders
Fatigue
|
95.0%
19/20 • 3 years
|
95.2%
20/21 • 3 years
|
85.7%
18/21 • 3 years
|
|
General disorders
Fever
|
15.0%
3/20 • 3 years
|
9.5%
2/21 • 3 years
|
9.5%
2/21 • 3 years
|
|
General disorders
Flu like symptoms
|
5.0%
1/20 • 3 years
|
9.5%
2/21 • 3 years
|
4.8%
1/21 • 3 years
|
|
General disorders
Localized edema
|
0.00%
0/20 • 3 years
|
9.5%
2/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
General disorders
Non-cardiac chest pain
|
20.0%
4/20 • 3 years
|
14.3%
3/21 • 3 years
|
23.8%
5/21 • 3 years
|
|
General disorders
Pain
|
20.0%
4/20 • 3 years
|
23.8%
5/21 • 3 years
|
19.0%
4/21 • 3 years
|
|
General disorders
Other general disorders, administration site conditions
|
5.0%
1/20 • 3 years
|
0.00%
0/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Immune system disorders
Allergic reaction
|
5.0%
1/20 • 3 years
|
0.00%
0/21 • 3 years
|
4.8%
1/21 • 3 years
|
|
Infections and infestations
Enterocolitis infectious
|
5.0%
1/20 • 3 years
|
0.00%
0/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Infections and infestations
Lung infection
|
10.0%
2/20 • 3 years
|
0.00%
0/21 • 3 years
|
9.5%
2/21 • 3 years
|
|
Infections and infestations
Mucosal infection
|
15.0%
3/20 • 3 years
|
19.0%
4/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Infections and infestations
Paronychia
|
5.0%
1/20 • 3 years
|
4.8%
1/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Infections and infestations
Rash pustular
|
5.0%
1/20 • 3 years
|
0.00%
0/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Infections and infestations
Sinusitis
|
5.0%
1/20 • 3 years
|
0.00%
0/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Infections and infestations
Skin infection
|
15.0%
3/20 • 3 years
|
19.0%
4/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Infections and infestations
Upper respiratory infection
|
10.0%
2/20 • 3 years
|
9.5%
2/21 • 3 years
|
14.3%
3/21 • 3 years
|
|
Infections and infestations
Urinary tract infection
|
10.0%
2/20 • 3 years
|
4.8%
1/21 • 3 years
|
4.8%
1/21 • 3 years
|
|
Infections and infestations
Other infections and infestations
|
10.0%
2/20 • 3 years
|
9.5%
2/21 • 3 years
|
9.5%
2/21 • 3 years
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/20 • 3 years
|
9.5%
2/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Injury, poisoning and procedural complications
Fall
|
10.0%
2/20 • 3 years
|
0.00%
0/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Injury, poisoning and procedural complications
Fracture
|
5.0%
1/20 • 3 years
|
0.00%
0/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Investigations
Weight loss
|
5.0%
1/20 • 3 years
|
4.8%
1/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
55.0%
11/20 • 3 years
|
71.4%
15/21 • 3 years
|
52.4%
11/21 • 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
20.0%
4/20 • 3 years
|
23.8%
5/21 • 3 years
|
4.8%
1/21 • 3 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/20 • 3 years
|
9.5%
2/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.0%
1/20 • 3 years
|
14.3%
3/21 • 3 years
|
4.8%
1/21 • 3 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
20.0%
4/20 • 3 years
|
19.0%
4/21 • 3 years
|
9.5%
2/21 • 3 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.0%
1/20 • 3 years
|
4.8%
1/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
4/20 • 3 years
|
14.3%
3/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
40.0%
8/20 • 3 years
|
19.0%
4/21 • 3 years
|
52.4%
11/21 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.0%
1/20 • 3 years
|
4.8%
1/21 • 3 years
|
19.0%
4/21 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
5.0%
1/20 • 3 years
|
14.3%
3/21 • 3 years
|
19.0%
4/21 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/20 • 3 years
|
4.8%
1/21 • 3 years
|
9.5%
2/21 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
15.0%
3/20 • 3 years
|
14.3%
3/21 • 3 years
|
4.8%
1/21 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
0.00%
0/20 • 3 years
|
0.00%
0/21 • 3 years
|
9.5%
2/21 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/20 • 3 years
|
9.5%
2/21 • 3 years
|
4.8%
1/21 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
2/20 • 3 years
|
0.00%
0/21 • 3 years
|
9.5%
2/21 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.0%
1/20 • 3 years
|
14.3%
3/21 • 3 years
|
4.8%
1/21 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.0%
5/20 • 3 years
|
33.3%
7/21 • 3 years
|
23.8%
5/21 • 3 years
|
|
Nervous system disorders
Dizziness
|
5.0%
1/20 • 3 years
|
47.6%
10/21 • 3 years
|
23.8%
5/21 • 3 years
|
|
Nervous system disorders
Dysgeusia
|
10.0%
2/20 • 3 years
|
19.0%
4/21 • 3 years
|
9.5%
2/21 • 3 years
|
|
Nervous system disorders
Headache
|
30.0%
6/20 • 3 years
|
42.9%
9/21 • 3 years
|
33.3%
7/21 • 3 years
|
|
Nervous system disorders
Memory impairment
|
5.0%
1/20 • 3 years
|
4.8%
1/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/20 • 3 years
|
0.00%
0/21 • 3 years
|
9.5%
2/21 • 3 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/20 • 3 years
|
14.3%
3/21 • 3 years
|
4.8%
1/21 • 3 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
30.0%
6/20 • 3 years
|
19.0%
4/21 • 3 years
|
23.8%
5/21 • 3 years
|
|
Nervous system disorders
Syncope
|
5.0%
1/20 • 3 years
|
9.5%
2/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Nervous system disorders
Tremor
|
5.0%
1/20 • 3 years
|
4.8%
1/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Nervous system disorders
Other nervous system disorders
|
0.00%
0/20 • 3 years
|
4.8%
1/21 • 3 years
|
9.5%
2/21 • 3 years
|
|
Psychiatric disorders
Anxiety
|
15.0%
3/20 • 3 years
|
14.3%
3/21 • 3 years
|
28.6%
6/21 • 3 years
|
|
Psychiatric disorders
Confusion
|
5.0%
1/20 • 3 years
|
0.00%
0/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Psychiatric disorders
Depression
|
15.0%
3/20 • 3 years
|
0.00%
0/21 • 3 years
|
4.8%
1/21 • 3 years
|
|
Psychiatric disorders
Insomnia
|
45.0%
9/20 • 3 years
|
42.9%
9/21 • 3 years
|
28.6%
6/21 • 3 years
|
|
Renal and urinary disorders
Acute kidney injury
|
5.0%
1/20 • 3 years
|
0.00%
0/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Renal and urinary disorders
Urinary frequency
|
5.0%
1/20 • 3 years
|
0.00%
0/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Renal and urinary disorders
Urinary incontinence
|
5.0%
1/20 • 3 years
|
0.00%
0/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Reproductive system and breast disorders
Breast pain
|
5.0%
1/20 • 3 years
|
0.00%
0/21 • 3 years
|
4.8%
1/21 • 3 years
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/20 • 3 years
|
14.3%
3/21 • 3 years
|
4.8%
1/21 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
15.0%
3/20 • 3 years
|
9.5%
2/21 • 3 years
|
4.8%
1/21 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
5.0%
1/20 • 3 years
|
0.00%
0/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
70.0%
14/20 • 3 years
|
71.4%
15/21 • 3 years
|
76.2%
16/21 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
50.0%
10/20 • 3 years
|
76.2%
16/21 • 3 years
|
66.7%
14/21 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.0%
2/20 • 3 years
|
14.3%
3/21 • 3 years
|
4.8%
1/21 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
5.0%
1/20 • 3 years
|
4.8%
1/21 • 3 years
|
4.8%
1/21 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
20.0%
4/20 • 3 years
|
4.8%
1/21 • 3 years
|
14.3%
3/21 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
5.0%
1/20 • 3 years
|
0.00%
0/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.0%
2/20 • 3 years
|
9.5%
2/21 • 3 years
|
4.8%
1/21 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
5.0%
1/20 • 3 years
|
0.00%
0/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
5.0%
1/20 • 3 years
|
0.00%
0/21 • 3 years
|
4.8%
1/21 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
5.0%
1/20 • 3 years
|
4.8%
1/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
15.0%
3/20 • 3 years
|
4.8%
1/21 • 3 years
|
4.8%
1/21 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
5.0%
1/20 • 3 years
|
0.00%
0/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
10.0%
2/20 • 3 years
|
23.8%
5/21 • 3 years
|
4.8%
1/21 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Other respiratory, thoracic and mediastinal disorders
|
10.0%
2/20 • 3 years
|
0.00%
0/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.0%
2/20 • 3 years
|
19.0%
4/21 • 3 years
|
4.8%
1/21 • 3 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
25.0%
5/20 • 3 years
|
28.6%
6/21 • 3 years
|
9.5%
2/21 • 3 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.0%
1/20 • 3 years
|
0.00%
0/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
5.0%
1/20 • 3 years
|
4.8%
1/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Skin and subcutaneous tissue disorders
Periorbital edema
|
20.0%
4/20 • 3 years
|
33.3%
7/21 • 3 years
|
9.5%
2/21 • 3 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.0%
4/20 • 3 years
|
14.3%
3/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
55.0%
11/20 • 3 years
|
42.9%
9/21 • 3 years
|
9.5%
2/21 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
20.0%
4/20 • 3 years
|
33.3%
7/21 • 3 years
|
4.8%
1/21 • 3 years
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
5.0%
1/20 • 3 years
|
4.8%
1/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
5.0%
1/20 • 3 years
|
0.00%
0/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Skin and subcutaneous tissue disorders
Other skin and subcutaneous tissue disorders
|
10.0%
2/20 • 3 years
|
14.3%
3/21 • 3 years
|
14.3%
3/21 • 3 years
|
|
Vascular disorders
Hematoma
|
5.0%
1/20 • 3 years
|
0.00%
0/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Vascular disorders
Hot flashes
|
15.0%
3/20 • 3 years
|
0.00%
0/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Vascular disorders
Hypertension
|
10.0%
2/20 • 3 years
|
14.3%
3/21 • 3 years
|
9.5%
2/21 • 3 years
|
|
Vascular disorders
Hypotension
|
5.0%
1/20 • 3 years
|
23.8%
5/21 • 3 years
|
0.00%
0/21 • 3 years
|
|
Vascular disorders
Thromboembolic event
|
20.0%
4/20 • 3 years
|
38.1%
8/21 • 3 years
|
23.8%
5/21 • 3 years
|
|
Vascular disorders
Visceral arterial ischemia
|
5.0%
1/20 • 3 years
|
0.00%
0/21 • 3 years
|
0.00%
0/21 • 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place