Trial Outcomes & Findings for Erlotinib, Paclitaxel, and Carboplatin Combined With Radiation Therapy for Stage III Non-Small Cell Lung Cancer (NCT NCT00278148)
NCT ID: NCT00278148
Last Updated: 2020-07-20
Results Overview
The Phase I portion of this study is to determine the Maximum Tolerated Dose (MTD) of combining OSI-774 with the paclitaxel-carboplatin chemoradiation protocol and to assess the safety and feasiblity of this combination.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
32 participants
Primary outcome timeframe
2 weeks after surgery
Results posted on
2020-07-20
Participant Flow
9 participants completed the phase I portion of the study. 3 of those subjects continued onto the phase II portion of the study and are included within the 26 participants.
Participant milestones
| Measure |
Dose Level A
Dose Level A: 50 mg OSI-774/50 mg/m2 Paclitaxel/2 AUC Carboplatin
|
Dose Level B
Dose Level B: 100 mg OSI-774/50 mg/m2 Paclitaxel/2 AUC Carboplatin
|
Dose Level C
Dose Level C: 150 mg OSI-774/50 mg/m2 Paclitaxel/2 AUC Carboplatin
|
|---|---|---|---|
|
Phase I - Dose Escalation
STARTED
|
4
|
2
|
3
|
|
Phase I - Dose Escalation
COMPLETED
|
4
|
2
|
3
|
|
Phase I - Dose Escalation
NOT COMPLETED
|
0
|
0
|
0
|
|
Phase II - Expansion Phase
STARTED
|
0
|
0
|
26
|
|
Phase II - Expansion Phase
COMPLETED
|
0
|
0
|
20
|
|
Phase II - Expansion Phase
NOT COMPLETED
|
0
|
0
|
6
|
Reasons for withdrawal
| Measure |
Dose Level A
Dose Level A: 50 mg OSI-774/50 mg/m2 Paclitaxel/2 AUC Carboplatin
|
Dose Level B
Dose Level B: 100 mg OSI-774/50 mg/m2 Paclitaxel/2 AUC Carboplatin
|
Dose Level C
Dose Level C: 150 mg OSI-774/50 mg/m2 Paclitaxel/2 AUC Carboplatin
|
|---|---|---|---|
|
Phase II - Expansion Phase
Disease progression
|
0
|
0
|
4
|
|
Phase II - Expansion Phase
Adverse Event
|
0
|
0
|
2
|
Baseline Characteristics
Erlotinib, Paclitaxel, and Carboplatin Combined With Radiation Therapy for Stage III Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Erlotinib, Paclitaxel, and Carboplatin With Radiation
n=32 Participants
All participants that went on study at the three dose levels.
Dose Level A: 50 mg OSI-774/50 mg/m2 Paclitaxel/2 AUC Carboplatin Dose Level B: 100 mg OSI-774/50 mg/m2 Paclitaxel/2 AUC Carboplatin Dose Level C: 150 mg OSI-774/50 mg/m2 Paclitaxel/2 AUC Carboplatin
|
|---|---|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 weeks after surgeryPopulation: participants enrolled in the phase I portion of the study
The Phase I portion of this study is to determine the Maximum Tolerated Dose (MTD) of combining OSI-774 with the paclitaxel-carboplatin chemoradiation protocol and to assess the safety and feasiblity of this combination.
Outcome measures
| Measure |
Erlotinib, Paclitaxel, and Carboplatin With Radiation
n=9 Participants
carboplatin: AUC2 weekly x 3 weeks
Tarceva: Daily
paclitaxel: 50mg/m2/weekly x 3 weeks
conventional surgery: conventional surgery
radiation therapy: 150 cGy bid
|
|---|---|
|
Maximum Tolerated Dose of Erlotinib Hydrochloride (Phase I)
|
150 mg daily
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Participants that completed adjuvant chemoradiation and maintenance erolotinib.
Number of patients who experienced grade \>/= 3 toxicities on maintanance erolotinib (OSI-774)
Outcome measures
| Measure |
Erlotinib, Paclitaxel, and Carboplatin With Radiation
n=20 Participants
carboplatin: AUC2 weekly x 3 weeks
Tarceva: Daily
paclitaxel: 50mg/m2/weekly x 3 weeks
conventional surgery: conventional surgery
radiation therapy: 150 cGy bid
|
|---|---|
|
Tolerability of Long-term OSI-774 (Phase II)
grade 3
|
4 Participants
|
|
Tolerability of Long-term OSI-774 (Phase II)
less than grade 3
|
16 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Participants that participated in phase II portion of the study
Number of participants with an pathological complete response rate using the RECIST criteria. Complete response: Disappearance of all measurable and evaluable disease Partial response: A 30% or greater decline in the sum of the longest diameter of target lesions compared to the baseline measurement. Progressive disease: A 20% or greater increase in the sum of the longest diameter of the target lesions compared to the baseline. Stable disease: Disease that did not meet the criteria for a CR / PR or progressive disease.
Outcome measures
| Measure |
Erlotinib, Paclitaxel, and Carboplatin With Radiation
n=26 Participants
carboplatin: AUC2 weekly x 3 weeks
Tarceva: Daily
paclitaxel: 50mg/m2/weekly x 3 weeks
conventional surgery: conventional surgery
radiation therapy: 150 cGy bid
|
|---|---|
|
Pathological Complete Response Rate
|
6 participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Participants that participated in the phase II of the study
Percent of participants still alive from the date of study entry to the date of the corresponding event (recurrence of death) or the date of final follow-up.
Outcome measures
| Measure |
Erlotinib, Paclitaxel, and Carboplatin With Radiation
n=26 Participants
carboplatin: AUC2 weekly x 3 weeks
Tarceva: Daily
paclitaxel: 50mg/m2/weekly x 3 weeks
conventional surgery: conventional surgery
radiation therapy: 150 cGy bid
|
|---|---|
|
Overall Survival
|
69 percentage of participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Participants that participated in the phase II of the study
Months from the date of study entry to the date of the corresponding event (recurrence of death) or the date of final follow-up
Outcome measures
| Measure |
Erlotinib, Paclitaxel, and Carboplatin With Radiation
n=26 Participants
carboplatin: AUC2 weekly x 3 weeks
Tarceva: Daily
paclitaxel: 50mg/m2/weekly x 3 weeks
conventional surgery: conventional surgery
radiation therapy: 150 cGy bid
|
|---|---|
|
Progression Free Survival (PFS)
|
41.8 months
Interval 9.2 to 51.8
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Data not collected
Estimated by the Kaplan-Meier method and summarized at various follow-up points as the number of patients remaining at risk, the event estimate, standard error, and median.From the date of study entry to the date of the corresponding event (recurrence of death) or the date of final follow-up, assessed up to 2 years
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: Data not collected
Estimated by the Kaplan-Meier method and summarized at various follow-up points as the number of patients remaining at risk, the event estimate, standard error, and median.From the date of study entry to the date of the corresponding event (recurrence of death) or the date of final follow-up, assessed up to 2 years
Outcome measures
Outcome data not reported
Adverse Events
Dose Level A:50 mg OSI-774/50 mg/m2
Serious events: 2 serious events
Other events: 4 other events
Deaths: 3 deaths
Dose Level B: 100 mg OSI-774/50 mg/m2
Serious events: 1 serious events
Other events: 2 other events
Deaths: 2 deaths
Dose Level C: 150 mg OSI-774/50 mg/m2
Serious events: 9 serious events
Other events: 26 other events
Deaths: 15 deaths
Serious adverse events
| Measure |
Dose Level A:50 mg OSI-774/50 mg/m2
n=4 participants at risk
50 mg OSI-774/50 mg/m2 Paclitaxel/2 AUC Carboplatin
|
Dose Level B: 100 mg OSI-774/50 mg/m2
n=2 participants at risk
100 mg OSI-774/50 mg/m2 Paclitaxel/2 AUC Carboplatin
|
Dose Level C: 150 mg OSI-774/50 mg/m2
n=26 participants at risk
150 mg OSI-774/50 mg/m2 Paclitaxel/2 AUC Carboplatin
|
|---|---|---|---|
|
Cardiac disorders
Cardiac Arrhythmia
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
3.8%
1/26 • Number of events 1 • Adverse events were collected over the duration of the study up to 3 years
|
|
Nervous system disorders
Confusion
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/26 • Adverse events were collected over the duration of the study up to 3 years
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
3.8%
1/26 • Number of events 2 • Adverse events were collected over the duration of the study up to 3 years
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
3.8%
1/26 • Number of events 2 • Adverse events were collected over the duration of the study up to 3 years
|
|
Nervous system disorders
Memory impairment
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/26 • Adverse events were collected over the duration of the study up to 3 years
|
|
Eye disorders
Vision-blurred vision
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/26 • Adverse events were collected over the duration of the study up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
3.8%
1/26 • Number of events 2 • Adverse events were collected over the duration of the study up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
3.8%
1/26 • Number of events 1 • Adverse events were collected over the duration of the study up to 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
3.8%
1/26 • Number of events 1 • Adverse events were collected over the duration of the study up to 3 years
|
|
Investigations
Amylase
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
3.8%
1/26 • Number of events 1 • Adverse events were collected over the duration of the study up to 3 years
|
|
Investigations
Lipase
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
3.8%
1/26 • Number of events 1 • Adverse events were collected over the duration of the study up to 3 years
|
|
General disorders
Pain - Abdomen NOS
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
3.8%
1/26 • Number of events 1 • Adverse events were collected over the duration of the study up to 3 years
|
|
Nervous system disorders
Seizure
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
3.8%
1/26 • Number of events 1 • Adverse events were collected over the duration of the study up to 3 years
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
3.8%
1/26 • Number of events 1 • Adverse events were collected over the duration of the study up to 3 years
|
|
Infections and infestations
Infection with unknown ANC - Skin (cellulitis)
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
3.8%
1/26 • Number of events 1 • Adverse events were collected over the duration of the study up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Lung
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
3.8%
1/26 • Number of events 1 • Adverse events were collected over the duration of the study up to 3 years
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
50.0%
1/2 • Number of events 1 • Adverse events were collected over the duration of the study up to 3 years
|
7.7%
2/26 • Number of events 3 • Adverse events were collected over the duration of the study up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
7.7%
2/26 • Number of events 4 • Adverse events were collected over the duration of the study up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
3.8%
1/26 • Number of events 1 • Adverse events were collected over the duration of the study up to 3 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
3.8%
1/26 • Number of events 1 • Adverse events were collected over the duration of the study up to 3 years
|
Other adverse events
| Measure |
Dose Level A:50 mg OSI-774/50 mg/m2
n=4 participants at risk
50 mg OSI-774/50 mg/m2 Paclitaxel/2 AUC Carboplatin
|
Dose Level B: 100 mg OSI-774/50 mg/m2
n=2 participants at risk
100 mg OSI-774/50 mg/m2 Paclitaxel/2 AUC Carboplatin
|
Dose Level C: 150 mg OSI-774/50 mg/m2
n=26 participants at risk
150 mg OSI-774/50 mg/m2 Paclitaxel/2 AUC Carboplatin
|
|---|---|---|---|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
50.0%
1/2 • Number of events 2 • Adverse events were collected over the duration of the study up to 3 years
|
38.5%
10/26 • Number of events 15 • Adverse events were collected over the duration of the study up to 3 years
|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
23.1%
6/26 • Number of events 6 • Adverse events were collected over the duration of the study up to 3 years
|
|
Blood and lymphatic system disorders
Hemoglobin
|
50.0%
2/4 • Number of events 8 • Adverse events were collected over the duration of the study up to 3 years
|
50.0%
1/2 • Number of events 5 • Adverse events were collected over the duration of the study up to 3 years
|
76.9%
20/26 • Number of events 64 • Adverse events were collected over the duration of the study up to 3 years
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
75.0%
3/4 • Number of events 6 • Adverse events were collected over the duration of the study up to 3 years
|
50.0%
1/2 • Number of events 2 • Adverse events were collected over the duration of the study up to 3 years
|
80.8%
21/26 • Number of events 57 • Adverse events were collected over the duration of the study up to 3 years
|
|
Blood and lymphatic system disorders
Lymphopenia
|
100.0%
4/4 • Number of events 16 • Adverse events were collected over the duration of the study up to 3 years
|
100.0%
2/2 • Number of events 15 • Adverse events were collected over the duration of the study up to 3 years
|
100.0%
26/26 • Number of events 142 • Adverse events were collected over the duration of the study up to 3 years
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
26.9%
7/26 • Number of events 12 • Adverse events were collected over the duration of the study up to 3 years
|
|
Blood and lymphatic system disorders
Platelets
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
34.6%
9/26 • Number of events 12 • Adverse events were collected over the duration of the study up to 3 years
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia - Atrial fibrillation
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
50.0%
1/2 • Number of events 1 • Adverse events were collected over the duration of the study up to 3 years
|
15.4%
4/26 • Number of events 4 • Adverse events were collected over the duration of the study up to 3 years
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia - Sinus tachycardia
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
7.7%
2/26 • Number of events 2 • Adverse events were collected over the duration of the study up to 3 years
|
|
Cardiac disorders
Ventricular arrhythmia - Ventricular tachycardia
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
7.7%
2/26 • Number of events 2 • Adverse events were collected over the duration of the study up to 3 years
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
7.7%
2/26 • Number of events 3 • Adverse events were collected over the duration of the study up to 3 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
11.5%
3/26 • Number of events 4 • Adverse events were collected over the duration of the study up to 3 years
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
100.0%
4/4 • Number of events 17 • Adverse events were collected over the duration of the study up to 3 years
|
100.0%
2/2 • Number of events 10 • Adverse events were collected over the duration of the study up to 3 years
|
80.8%
21/26 • Number of events 51 • Adverse events were collected over the duration of the study up to 3 years
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
11.5%
3/26 • Number of events 3 • Adverse events were collected over the duration of the study up to 3 years
|
|
General disorders
Insomnia
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
26.9%
7/26 • Number of events 11 • Adverse events were collected over the duration of the study up to 3 years
|
|
General disorders
Rigors/chills
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
23.1%
6/26 • Number of events 10 • Adverse events were collected over the duration of the study up to 3 years
|
|
General disorders
Sweating (diaphoresis)
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
11.5%
3/26 • Number of events 3 • Adverse events were collected over the duration of the study up to 3 years
|
|
Investigations
Weight loss
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
38.5%
10/26 • Number of events 17 • Adverse events were collected over the duration of the study up to 3 years
|
|
Injury, poisoning and procedural complications
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
11.5%
3/26 • Number of events 4 • Adverse events were collected over the duration of the study up to 3 years
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
11.5%
3/26 • Number of events 3 • Adverse events were collected over the duration of the study up to 3 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
38.5%
10/26 • Number of events 18 • Adverse events were collected over the duration of the study up to 3 years
|
|
Vascular disorders
Flushing
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
11.5%
3/26 • Number of events 5 • Adverse events were collected over the duration of the study up to 3 years
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
38.5%
10/26 • Number of events 11 • Adverse events were collected over the duration of the study up to 3 years
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
15.4%
4/26 • Number of events 6 • Adverse events were collected over the duration of the study up to 3 years
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
100.0%
2/2 • Number of events 3 • Adverse events were collected over the duration of the study up to 3 years
|
50.0%
13/26 • Number of events 56 • Adverse events were collected over the duration of the study up to 3 years
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
75.0%
3/4 • Number of events 7 • Adverse events were collected over the duration of the study up to 3 years
|
100.0%
2/2 • Number of events 10 • Adverse events were collected over the duration of the study up to 3 years
|
65.4%
17/26 • Number of events 65 • Adverse events were collected over the duration of the study up to 3 years
|
|
Injury, poisoning and procedural complications
Rash: dermatitis associated with radiation - Chemoradiation
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
11.5%
3/26 • Number of events 3 • Adverse events were collected over the duration of the study up to 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
75.0%
3/4 • Number of events 6 • Adverse events were collected over the duration of the study up to 3 years
|
50.0%
1/2 • Number of events 2 • Adverse events were collected over the duration of the study up to 3 years
|
69.2%
18/26 • Number of events 28 • Adverse events were collected over the duration of the study up to 3 years
|
|
Gastrointestinal disorders
Constipation
|
50.0%
2/4 • Number of events 3 • Adverse events were collected over the duration of the study up to 3 years
|
50.0%
1/2 • Number of events 1 • Adverse events were collected over the duration of the study up to 3 years
|
42.3%
11/26 • Number of events 14 • Adverse events were collected over the duration of the study up to 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
19.2%
5/26 • Number of events 6 • Adverse events were collected over the duration of the study up to 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
75.0%
3/4 • Number of events 6 • Adverse events were collected over the duration of the study up to 3 years
|
100.0%
2/2 • Number of events 8 • Adverse events were collected over the duration of the study up to 3 years
|
88.5%
23/26 • Number of events 79 • Adverse events were collected over the duration of the study up to 3 years
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
15.4%
4/26 • Number of events 5 • Adverse events were collected over the duration of the study up to 3 years
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
50.0%
2/4 • Number of events 5 • Adverse events were collected over the duration of the study up to 3 years
|
100.0%
2/2 • Number of events 3 • Adverse events were collected over the duration of the study up to 3 years
|
53.8%
14/26 • Number of events 20 • Adverse events were collected over the duration of the study up to 3 years
|
|
Gastrointestinal disorders
Esophagitis
|
75.0%
3/4 • Number of events 6 • Adverse events were collected over the duration of the study up to 3 years
|
50.0%
1/2 • Number of events 2 • Adverse events were collected over the duration of the study up to 3 years
|
23.1%
6/26 • Number of events 6 • Adverse events were collected over the duration of the study up to 3 years
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
11.5%
3/26 • Number of events 6 • Adverse events were collected over the duration of the study up to 3 years
|
|
Gastrointestinal disorders
Gastritis (including bile reflux gastritis)
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
7.7%
2/26 • Number of events 2 • Adverse events were collected over the duration of the study up to 3 years
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
50.0%
2/4 • Number of events 2 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
30.8%
8/26 • Number of events 13 • Adverse events were collected over the duration of the study up to 3 years
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - Esophagus
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
15.4%
4/26 • Number of events 8 • Adverse events were collected over the duration of the study up to 3 years
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - Oral cavity
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
46.2%
12/26 • Number of events 20 • Adverse events were collected over the duration of the study up to 3 years
|
|
Gastrointestinal disorders
Nausea
|
75.0%
3/4 • Number of events 6 • Adverse events were collected over the duration of the study up to 3 years
|
100.0%
2/2 • Number of events 2 • Adverse events were collected over the duration of the study up to 3 years
|
23.1%
6/26 • Number of events 13 • Adverse events were collected over the duration of the study up to 3 years
|
|
Nervous system disorders
Taste alteration (dysgeusia)
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
34.6%
9/26 • Number of events 17 • Adverse events were collected over the duration of the study up to 3 years
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
2/4 • Number of events 2 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
23.1%
6/26 • Number of events 19 • Adverse events were collected over the duration of the study up to 3 years
|
|
Gastrointestinal disorders
Hemorrhage, GI - Rectum
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
7.7%
2/26 • Number of events 2 • Adverse events were collected over the duration of the study up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Nose
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
30.8%
8/26 • Number of events 8 • Adverse events were collected over the duration of the study up to 3 years
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Urinary tract NOS
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
7.7%
2/26 • Number of events 2 • Adverse events were collected over the duration of the study up to 3 years
|
|
Infections and infestations
Infection with unknown ANC - Pharynx
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
3.8%
1/26 • Number of events 1 • Adverse events were collected over the duration of the study up to 3 years
|
|
Infections and infestations
Opportunistic infection associated with >=Grade 2 Lymphopenia
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
7.7%
2/26 • Number of events 2 • Adverse events were collected over the duration of the study up to 3 years
|
|
General disorders
Edema: limb
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
50.0%
1/2 • Number of events 1 • Adverse events were collected over the duration of the study up to 3 years
|
3.8%
1/26 • Number of events 1 • Adverse events were collected over the duration of the study up to 3 years
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over the duration of the study up to 3 years
|
50.0%
1/2 • Number of events 2 • Adverse events were collected over the duration of the study up to 3 years
|
42.3%
11/26 • Number of events 19 • Adverse events were collected over the duration of the study up to 3 years
|
|
Investigations
Alkaline phosphatase
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
50.0%
1/2 • Number of events 1 • Adverse events were collected over the duration of the study up to 3 years
|
15.4%
4/26 • Number of events 4 • Adverse events were collected over the duration of the study up to 3 years
|
|
Blood and lymphatic system disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
50.0%
1/2 • Number of events 2 • Adverse events were collected over the duration of the study up to 3 years
|
53.8%
14/26 • Number of events 18 • Adverse events were collected over the duration of the study up to 3 years
|
|
Investigations
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
50.0%
1/2 • Number of events 1 • Adverse events were collected over the duration of the study up to 3 years
|
50.0%
13/26 • Number of events 20 • Adverse events were collected over the duration of the study up to 3 years
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
11.5%
3/26 • Number of events 4 • Adverse events were collected over the duration of the study up to 3 years
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
15.4%
4/26 • Number of events 5 • Adverse events were collected over the duration of the study up to 3 years
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over the duration of the study up to 3 years
|
50.0%
1/2 • Number of events 1 • Adverse events were collected over the duration of the study up to 3 years
|
57.7%
15/26 • Number of events 33 • Adverse events were collected over the duration of the study up to 3 years
|
|
Investigations
Creatinine
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
7.7%
2/26 • Number of events 10 • Adverse events were collected over the duration of the study up to 3 years
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
100.0%
4/4 • Number of events 15 • Adverse events were collected over the duration of the study up to 3 years
|
100.0%
2/2 • Number of events 9 • Adverse events were collected over the duration of the study up to 3 years
|
96.2%
25/26 • Number of events 136 • Adverse events were collected over the duration of the study up to 3 years
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
50.0%
1/2 • Number of events 2 • Adverse events were collected over the duration of the study up to 3 years
|
7.7%
2/26 • Number of events 2 • Adverse events were collected over the duration of the study up to 3 years
|
|
Renal and urinary disorders
Hemoglobinuria
|
50.0%
2/4 • Number of events 2 • Adverse events were collected over the duration of the study up to 3 years
|
50.0%
1/2 • Number of events 1 • Adverse events were collected over the duration of the study up to 3 years
|
23.1%
6/26 • Number of events 12 • Adverse events were collected over the duration of the study up to 3 years
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
19.2%
5/26 • Number of events 6 • Adverse events were collected over the duration of the study up to 3 years
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
50.0%
2/4 • Number of events 2 • Adverse events were collected over the duration of the study up to 3 years
|
50.0%
1/2 • Number of events 1 • Adverse events were collected over the duration of the study up to 3 years
|
34.6%
9/26 • Number of events 10 • Adverse events were collected over the duration of the study up to 3 years
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over the duration of the study up to 3 years
|
50.0%
1/2 • Number of events 1 • Adverse events were collected over the duration of the study up to 3 years
|
38.5%
10/26 • Number of events 13 • Adverse events were collected over the duration of the study up to 3 years
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
50.0%
2/4 • Number of events 6 • Adverse events were collected over the duration of the study up to 3 years
|
50.0%
1/2 • Number of events 1 • Adverse events were collected over the duration of the study up to 3 years
|
38.5%
10/26 • Number of events 17 • Adverse events were collected over the duration of the study up to 3 years
|
|
Metabolism and nutrition disorders
Uric acid, serum-high (hyperuricemia)
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
7.7%
2/26 • Number of events 3 • Adverse events were collected over the duration of the study up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Extremity-lower
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
7.7%
2/26 • Number of events 2 • Adverse events were collected over the duration of the study up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
7.7%
2/26 • Number of events 2 • Adverse events were collected over the duration of the study up to 3 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
50.0%
1/2 • Number of events 1 • Adverse events were collected over the duration of the study up to 3 years
|
23.1%
6/26 • Number of events 12 • Adverse events were collected over the duration of the study up to 3 years
|
|
Psychiatric disorders
Mood alteration - Anxiety/Agitation
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
34.6%
9/26 • Number of events 13 • Adverse events were collected over the duration of the study up to 3 years
|
|
Psychiatric disorders
Mood alteration - Depression
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
11.5%
3/26 • Number of events 6 • Adverse events were collected over the duration of the study up to 3 years
|
|
Nervous system disorders
mild paresthesias in hands/feet
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over the duration of the study up to 3 years
|
50.0%
1/2 • Number of events 1 • Adverse events were collected over the duration of the study up to 3 years
|
3.8%
1/26 • Number of events 2 • Adverse events were collected over the duration of the study up to 3 years
|
|
Nervous system disorders
Neuropathy: motor
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
7.7%
2/26 • Number of events 2 • Adverse events were collected over the duration of the study up to 3 years
|
|
Nervous system disorders
Neuropathy: sensory
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
23.1%
6/26 • Number of events 9 • Adverse events were collected over the duration of the study up to 3 years
|
|
Eye disorders
Dry eye syndrome
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
7.7%
2/26 • Number of events 2 • Adverse events were collected over the duration of the study up to 3 years
|
|
Eye disorders
Ocular surface disease
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
7.7%
2/26 • Number of events 3 • Adverse events were collected over the duration of the study up to 3 years
|
|
Eye disorders
Watery eye (epiphora, tearing)
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
7.7%
2/26 • Number of events 3 • Adverse events were collected over the duration of the study up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
50.0%
2/4 • Number of events 3 • Adverse events were collected over the duration of the study up to 3 years
|
50.0%
1/2 • Number of events 2 • Adverse events were collected over the duration of the study up to 3 years
|
11.5%
3/26 • Number of events 3 • Adverse events were collected over the duration of the study up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Chest wall
|
50.0%
2/4 • Number of events 3 • Adverse events were collected over the duration of the study up to 3 years
|
100.0%
2/2 • Number of events 3 • Adverse events were collected over the duration of the study up to 3 years
|
19.2%
5/26 • Number of events 9 • Adverse events were collected over the duration of the study up to 3 years
|
|
General disorders
Pain - Chest/thorax NOS
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over the duration of the study up to 3 years
|
50.0%
1/2 • Number of events 2 • Adverse events were collected over the duration of the study up to 3 years
|
15.4%
4/26 • Number of events 13 • Adverse events were collected over the duration of the study up to 3 years
|
|
Nervous system disorders
Pain - Head/headache
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
11.5%
3/26 • Number of events 3 • Adverse events were collected over the duration of the study up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
11.5%
3/26 • Number of events 4 • Adverse events were collected over the duration of the study up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Muscle
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
50.0%
1/2 • Number of events 1 • Adverse events were collected over the duration of the study up to 3 years
|
11.5%
3/26 • Number of events 4 • Adverse events were collected over the duration of the study up to 3 years
|
|
General disorders
Pain - Other NOS
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
34.6%
9/26 • Number of events 30 • Adverse events were collected over the duration of the study up to 3 years
|
|
Skin and subcutaneous tissue disorders
Pain - Skin
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
7.7%
2/26 • Number of events 2 • Adverse events were collected over the duration of the study up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pain - Throat/pharynx/larynx
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
7.7%
2/26 • Number of events 2 • Adverse events were collected over the duration of the study up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
50.0%
1/2 • Number of events 2 • Adverse events were collected over the duration of the study up to 3 years
|
61.5%
16/26 • Number of events 28 • Adverse events were collected over the duration of the study up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
50.0%
2/4 • Number of events 2 • Adverse events were collected over the duration of the study up to 3 years
|
50.0%
1/2 • Number of events 3 • Adverse events were collected over the duration of the study up to 3 years
|
65.4%
17/26 • Number of events 27 • Adverse events were collected over the duration of the study up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs (hiccups, singultus)
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
7.7%
2/26 • Number of events 3 • Adverse events were collected over the duration of the study up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
50.0%
1/2 • Number of events 2 • Adverse events were collected over the duration of the study up to 3 years
|
3.8%
1/26 • Number of events 1 • Adverse events were collected over the duration of the study up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cavity/paranasal sinus reactions
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
15.4%
4/26 • Number of events 8 • Adverse events were collected over the duration of the study up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
50.0%
1/2 • Number of events 1 • Adverse events were collected over the duration of the study up to 3 years
|
30.8%
8/26 • Number of events 8 • Adverse events were collected over the duration of the study up to 3 years
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
7.7%
2/26 • Number of events 2 • Adverse events were collected over the duration of the study up to 3 years
|
|
Vascular disorders
Phlebitis (including superficial thrombosis)
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
0.00%
0/2 • Adverse events were collected over the duration of the study up to 3 years
|
7.7%
2/26 • Number of events 2 • Adverse events were collected over the duration of the study up to 3 years
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
0.00%
0/4 • Adverse events were collected over the duration of the study up to 3 years
|
50.0%
1/2 • Number of events 1 • Adverse events were collected over the duration of the study up to 3 years
|
11.5%
3/26 • Number of events 4 • Adverse events were collected over the duration of the study up to 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place